Medical device recalls: March 2009
The FDA posted 113 medical device recall records in March 2009, from 40 recall events by 35 companies. 113 have not been classified yet.
Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.
Companies with the most recall events
- Welch Allyn Protocol, Inc · 3 events, 3 records
- Zimmer Inc. · 3 events, 3 records
- Stryker Instruments Div. of Stryker Corporation · 2 events, 11 records
- Medtronic Neurosurgery · 1 event, 29 records
- Rochester Medical Corp · 1 event, 14 records
- Tri-State Hospital Supply Corporation · 1 event, 13 records
- Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK · 1 event, 4 records
- Boston Scientific Corp · 1 event, 3 records
FDA root cause
- Device Design · 34
- Packaging process control · 15
- Package design/selection · 14
- Process control · 13
- Component design/selection · 11
- Pending · 6
- Software design · 4
- Packaging · 4
Not yet classified (113)
The FDA has posted these records but has not published a class for them yet.
- Z-1020-2009 · Theragenics Corporation · posted Mar 31, 2009 · Terminated
Some pouches were found to have weak seals potentially compromising sterility.
- Z-1043-2009 · Lexamed · posted Mar 31, 2009 · Terminated
Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.
- Z-1073-2009 · Stelkast Co · posted Mar 31, 2009 · Terminated
A possible breach of the sterile barrier packaging (Tyvek pouch).
- Z-1089-2009 · Zeus Scientific Inc · posted Mar 31, 2009 · Terminated
The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266.
- Z-1042-2009 · Diasorin Inc. · posted Mar 30, 2009 · Terminated
DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the LIAISON (R) Analyzer.
- Z-1052-2009 · Stryker Instruments Div. of Stryker Corporation · posted Mar 30, 2009 · Terminated
Bur guards were distributed without an expiration date, and if they are used after they have expired it could result in the patient or operating room staff experiencing a burn or laceration.
- Z-1124-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1125-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1126-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1127-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1128-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1129-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1130-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1131-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1132-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1133-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1134-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1135-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1136-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1137-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1138-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1139-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1140-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1141-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1142-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1143-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1144-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1145-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1146-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1147-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1148-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1149-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1150-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1151-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1152-2009 · Medtronic Neurosurgery · posted Mar 27, 2009 · Terminated
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Z-1157-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1158-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1159-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1160-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1161-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Lee Medical Neonatal/Ped PICC Insertion Tray, sterile, 15 per case, Lee Medical, Inc. Franklin, TN ↗Z-1162-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1163-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1164-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1165-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1166-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1167-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1168-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1169-2009 · Tri-State Hospital Supply Corporation · posted Mar 25, 2009 · Terminated
Lack of assurance of sterility, as the package seals may be inadequate.
- Z-1009-2009 · Roche Diagnostics Corp. · posted Mar 24, 2009 · Terminated
Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. Without the glue, the cap can become loose or misaligned. The effect of these faulty valves is that they…
- Z-1040-2009 · Leica Microsystems, Inc. · posted Mar 24, 2009 · Terminated
A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.
- Z-1041-2009 · Bio-Rad Laboratories Inc · posted Mar 24, 2009 · Terminated
Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
- Z-1008-2009 · Remel, Inc · posted Mar 20, 2009 · Terminated
Control and test wells are reversed on some of the reaction cards.
- Z-1090-2009 · Bd Diagnostic Systems Tripath · posted Mar 19, 2009 · Terminated
Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results.
- Z-0642-2009 · Medtronic Cardiovascular · posted Mar 18, 2009 · Terminated
Mislabeled: Product may contain wrong instructions for use-- may contain International IFU instead of the correct US (for Biliary indication use only) IFU.
- Z-1070-2009 · Lifescan Inc · posted Mar 17, 2009 · Terminated
Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
- Z-1088-2009 · Biosite Inc · posted Mar 17, 2009 · Terminated
The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market surveillance thresholds for…
- Z-1074-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1075-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1076-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1077-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1078-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1079-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1080-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1081-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1082-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1083-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1084-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1085-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1086-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1087-2009 · Rochester Medical Corp · posted Mar 16, 2009 · Terminated
Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Z-1014-2009 · Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK · posted Mar 12, 2009 · Terminated
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
- Z-1015-2009 · Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK · posted Mar 12, 2009 · Terminated
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
- Z-1016-2009 · Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK · posted Mar 12, 2009 · Terminated
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
- Z-1017-2009 · Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK · posted Mar 12, 2009 · Terminated
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
- Z-1091-2009 · Pointe Scientific, Inc. · posted Mar 12, 2009 · Terminated
The product is unable to maintain the specification for linearity through the shelf life of the product.
- Z-1092-2009 · GE Medical Systems, LLC · posted Mar 12, 2009 · Terminated
GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.
- Z-1093-2009 · GE Medical Systems, LLC · posted Mar 12, 2009 · Terminated
GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.
- Z-1010-2009 · Boston Scientific Corp · posted Mar 11, 2009 · Terminated
The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.
- Z-1011-2009 · Boston Scientific Corp · posted Mar 11, 2009 · Terminated
The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.
- Z-1012-2009 · Boston Scientific Corp · posted Mar 11, 2009 · Terminated
The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.
- Z-1005-2009 · Welch Allyn Protocol, Inc · posted Mar 10, 2009 · Terminated
Potential for device to shut down prematurely under certain circumstances.
- Z-1007-2009 · Welch Allyn Protocol, Inc · posted Mar 10, 2009 · Terminated
Potential for device to deliver less than the programmed energy.
- Z-1021-2009 · Stryker Instruments Div. of Stryker Corporation · posted Mar 10, 2009 · Terminated
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
- Z-1022-2009 · Stryker Instruments Div. of Stryker Corporation · posted Mar 10, 2009 · Terminated
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
- Z-1023-2009 · Stryker Instruments Div. of Stryker Corporation · posted Mar 10, 2009 · Terminated
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
- Z-1024-2009 · Stryker Instruments Div. of Stryker Corporation · posted Mar 10, 2009 · Terminated
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
- Z-1025-2009 · Stryker Instruments Div. of Stryker Corporation · posted Mar 10, 2009 · Terminated
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
- Z-1026-2009 · Stryker Instruments Div. of Stryker Corporation · posted Mar 10, 2009 · Terminated
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
- Z-1027-2009 · Stryker Instruments Div. of Stryker Corporation · posted Mar 10, 2009 · Terminated
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
- Z-1028-2009 · Stryker Instruments Div. of Stryker Corporation · posted Mar 10, 2009 · Terminated
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
- Z-1029-2009 · Stryker Instruments Div. of Stryker Corporation · posted Mar 10, 2009 · Terminated
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
- Z-1030-2009 · Stryker Instruments Div. of Stryker Corporation · posted Mar 10, 2009 · Terminated
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
- Z-1059-2009 · Cook Endoscopy · posted Mar 10, 2009 · Terminated
The snare head is hexagonal but the handle and packaging indicate an oval reorder number.
- Z-1060-2009 · Medtronic Neuromodulation · posted Mar 10, 2009 · Terminated
Reported incidents of needle retraction failure when using the PROSTIVA RF Model 8929 Hand Piece. The Medtronic Prostiva RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System.
- Z-0996-2009 · Zimmer Inc. · posted Mar 9, 2009 · Terminated
The package contains 11 mm screws instead of the specified 6 mm screws.
- Z-1006-2009 · Welch Allyn Protocol, Inc · posted Mar 9, 2009 · Terminated
Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;
- Z-1018-2009 · Smiths Medical MD, Inc. · posted Mar 9, 2009 · Terminated
Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 ("Pump") have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may render the Pump…
- Z-1019-2009 · Smiths Medical MD, Inc. · posted Mar 9, 2009 · Terminated
Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 ("Pump") have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may render the Pump…
- Z-0953-2009 · Millipore Corporation · posted Mar 6, 2009 · Terminated
Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B.
- Z-0954-2009 · Millipore Corporation · posted Mar 6, 2009 · Terminated
Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B.
- Z-1034-2009 · Integra LifeSciences Corp · posted Mar 6, 2009 · Terminated
Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.
- Z-1035-2009 · Integra LifeSciences Corp · posted Mar 6, 2009 · Terminated
Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.
- Z-1032-2009 · Intelifuse Inc · posted Mar 5, 2009 · Terminated
Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings.
- Z-1033-2009 · Intelifuse Inc · posted Mar 5, 2009 · Terminated
Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings.
- Z-0992-2009 · Ethicon, Inc. · posted Mar 4, 2009 · Terminated
A hospital reported to their Ethicon sales representative that they had an "unmarked" box of bone was on their shipping dock that they could not receive due to lack of appropriate documentation. Upon investigation, this box was determined to be missing…
- Z-0997-2009 · Covidien Limited · posted Mar 4, 2009 · Terminated
Difficulty inserting an obturator and/or suction catheter into the tracheostomy tube.
- Z-1031-2009 · Zimmer Inc. · posted Mar 4, 2009 · Terminated
Some of the torque wrenches apply less than the minimum torque to the screw locking cap when the torque indicators are aligned as described in the surgical technique.
- Z-0947-2009 · Medtronic Xomed, Inc. · posted Mar 3, 2009 · Terminated
Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.
- Z-0955-2009 · Animas Corporation · posted Mar 3, 2009 · Terminated
incorrect dosing recommendation
- Z-1013-2009 · Stryker Howmedica Osteonics Corp. · posted Mar 3, 2009 · Terminated
Stryker Orthopaedics became aware of a lot for lot mix-up between part numbers 5532-G-713, lot code LBD528 (Triathlon X3 Posterior Stabilized Tibial Insert, size 7-13 mm) and part 5532-G-813, lot code LBD512 (Triathlon X3 Posterior Stabilized Tibial Insert…
- Z-0985-2009 · Zimmer Inc. · posted Mar 2, 2009 · Terminated
Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use the initial surgeon profile parameter values in the calculation of…
- Z-1037-2009 · Baxter Healthcare Corp. · posted Mar 2, 2009 · Terminated
Baxter has identified failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps.
- Z-1038-2009 · Baxter Healthcare Corp. · posted Mar 2, 2009 · Terminated
Baxter has identified failure codes that lead to a delay or an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps.
Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.