Equinoxe 320-10-00Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
Quick summary
This Exactech Equinoxe shoulder replacement has 130 adverse event reports on record, with no deaths and 130 injuries. The reports mostly describe the plastic liner separating from the metal tray, with some mentioning dislocation, loosening, or pain. There are no recalls naming this device. The last 12 months show 19 reports, compared with 68 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 132
- Deaths reported
- 0
- Injuries reported
- 132
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 10885862086419), received between Apr 3, 2019 and Sep 29, 2026 — classified as 132 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (97 reports).
13 other recalls cover devices cleared under the same FDA submission (K063569); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component97
- Naturally Worn22
- Device Dislodged or Dislocated18
- Unstable9
- Adverse Event Without Identified Device or Use Problem8
- Fracture8
- Loosening of Implant Not Related to Bone-Ingrowth3
- Break2
Patient problems
- Insufficient Information42
- Joint Dislocation32
- Pain29
- Metal Related Pathology18
- Joint Laxity13
- Failure of Implant11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Implant Pain6
Recent adverse event reports
The 25 most recent of 132 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Detachment of Device or Device Component
Patient problems: Fall
MAUDE report 50936145 ↗InjurySep 14, 2026Detachment of Device or Device Component; Naturally Worn
It was reported that this patient underwent a left shoulder replacement. Subsequently, the patient experienced pain. Upon evaluation, the polyethylene component was found to be dislodged. The patient underwent revision surgery to address the dislodged polyethylene component. The patient was last known to be in stable condition following the event. No further information is available.
Patient problems: Pain
MAUDE report 50754788 ↗InjurySep 8, 2026Detachment of Device or Device Component; Naturally Worn
Report #2 of 2 for this event.As reported, approximately two (2) years post op the initial right total shoulder arthroplasty, this patient was revised due to anterior shoulder pain. When operated on it was noted the joint was filled with frank metallosis and the polyethylene component was very worn and dislocated. Tray damaged. The patient was last known to be in stable condition. No additional information is available.
Patient problems: Joint Dislocation; Metal Related Pathology
MAUDE report 50673817 ↗InjuryAug 3, 2026Detachment of Device or Device Component
As reported by the Equinoxe Shoulder Study, the patient underwent an initial right reverse total shoulder arthroplasty. Subsequently, the patient was revised due to poly dissociation. The humeral liner and humeral tray were removed. The outcome is considered to be continuing.
Patient problems: Insufficient Information
MAUDE report 50113364 ↗InjuryJun 11, 2026Unstable; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT, WHO HAD A LEFT TSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT PRESENTED WITH AN UNSTABLE SHOULDER AND REQUIRED SURGERY TO REDUCE THE JOINT STABILITY. DURING THE CASE, IT BECAME CLEAR OF WHAT THE ISSUE WAS AS THE POLY WAS FLOATING AROUND IN THE JOINT SPACE AND WAS NOT LOCKED INTO THE HUMERAL TRAY. THERE WAS LOTS OF BLACK TISSUE AND METALLOSIS SURROUNDING THE IMPLANTS. THE 38MM GLENOSPHERE AND GLENOSPHERE LOCKING SCREW WERE EXPLANTED ALONG WITH THE 38MM +2.5MM CONSTRAINED LINER, +0MM HUMERAL TRAY AND TORQUE SCREW. THEY UPSIZED AND REIMPLANTED A 42MM GLENOSPHERE AND GLENOSPHERE LOCKING SCREW, AND A 42MM +2.5MM LINER, +0MM HUMERAL TRAY AND TORQUE SCREW. THE GLENOID BASEPLATE AND HUMERAL STEM WERE LEFT IN AS THEY WERE WELL FIXED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY IMAGES WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THE HOSPITAL WON'T RELEASE THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.
Patient problems: Joint Laxity; Metal Related Pathology
MAUDE report 25479814 ↗InjuryJun 3, 2026Naturally Worn
IT WAS REPORTED THAT A 71 YO MALE PATIENT, WHO HAD A LEFT RTSA, UNDERWENT A REVISION PROCEDURE. THE REPORTED INFORMATION INDICATED THE PATIENT HAD A SUCCESSFUL SHOULDER REPLACEMENT, HOWEVER THE STEM HAS SINCE LOOSENED RESULTING IN A DISLOCATION. ADDITIONAL INFORMATION FROM THE CLINICAL STUDY NOTES THE PATIENT'S DOG JUMPLED ON HIM AND HE FELT A SUDDEN ONSET OF PAIN. X-RAY IMAGES SHOWED DISLOCATION AND MOVEMENT OF THE HUMERAL COMPONENT. AS SUCH, A SINGLE STAGE REVISION WAS UNDERTAKEN, SO THAT THE STEM COULD BE CEMENTED. THEY WERE REVISED TO A RTSA, WITH A CEMENTED STEM FOR ROTATIONAL STABILITY AND AN INCREASE IN LINER SIZE TO 38+2.5MM FOR INCREASED LENGTHENING. THE IMPLANTS WERE REMOVED AND REPLACED WITH NO ISSUES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO FURTHER INFORMATION. THIS IS 1 OF 4 REPORTS.
Patient problems: Aseptic loosening; Joint Dislocation; Pain
MAUDE report 25382179 ↗InjuryJun 1, 2026Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT A PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS UNSTABLE AND WAS DISLOCATING REQUIRING THE REVISION TO REGAIN THEIR JOINT STABILITY. DURING THE SURGERY, THERE WERE CLEAR SIGNS OF METALLOSIS AND BLACK TISSUE. THE POLY WAS EASILY REMOVED, AND THE SURGEON STATED THAT THE POLY WASN'T REALLY LOCKED INTO THE HUMERAL TRAY BUT WAS JUST SITTING ON TOP OF IT. THE SURGEON REMOVED THE 42MM +2.5 POLY AND THE +0 HUMERAL TRAY AND TORQUE SCREW AS WELL AS THE 42MM GLENOSPHERE AND GLENOSPHERE LOCKING SCREW. THE SURGEON KEPT THE 7MM PRESERVE STEM IMPLANTED AS IT WAS WELL FIXED AND ALSO KEPT THE GLENOID BASEPLATE IMPLANTED AND THE 3 PERIPHERAL SCREWS. TO INCREASE JOINT STABILITY, THE SURGEON RE-IMPLANTED A 42MM +4 LAT. GLENOSPHERE AND LOCKING SCREW ON THE GLENOID SIDE AND ON THE HUMERAL SIDE, HE IMPLANTED A +5MM HUMERAL TRAY AND TORQUE SCREW WITH A 42MM +0 CONSTRAINED LINER. THE PATIENT WAS STABLE WITH THESE IMPLANTS. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE HOSPITAL W
Patient problems: Joint Dislocation; Joint Laxity; Metal Related Pathology
MAUDE report 25355840 ↗InjuryMay 26, 2026Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED, APPROXIMATELY 1 YEAR AND 1 MONTH POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WENT TO WASH THEIR HAIR AND FELT A POP AND PAIN. ON EXAMINATION OF AN X-RAY IT SHOWED THAT THERE WERE MULTIPLE FIXATION SCREWS BROKEN BEHIND THE GLENOID PLATE. THE PATIENT WAS REVISED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Pain
MAUDE report 25281092 ↗InjuryMay 20, 2026Detachment of Device or Device Component
AS REPORTED, APPROXIMATELY 3 YEARS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLY DISASSOCIATION. THE PATIENT WAS REVISED TO COMPETITOR DEVICES. THERE WERE PARTS/FRAGMENTS THAT WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Insufficient Information
MAUDE report 25230274 ↗InjuryApr 30, 2026Detachment of Device or Device Component
AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 7 YEARS AND 10 MONTHS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLY DISASSOCIATION FROM TRAY. NO TRAUMA NOTED; WOKE UP WITH SHARP PAIN. THE OUTCOME IS CONSIDERED TO BE RESOLVED.
Patient problems: Pain
MAUDE report 25046337 ↗InjuryApr 27, 2026Unstable; Detachment of Device or Device Component
IT WAS REPORTED THAT THIS PATIENT UNDERWENT A RIGHT SHOULDER REPLACEMENT. SUBSEQUENTLY, THE PATIENT'S POLY DISSOCIATED WHICH LED TO PAIN AND INSTABILITY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Laxity; Pain
MAUDE report 25007233 ↗InjuryApr 22, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT, WHO HAD A LEFT RTSA, UNDERWENT A REVISION PROCEDURE DUE TO POLYETHYLENE LINER DISASSOCIATION. THE LINER SEPARATED FROM THE HUMERAL TRAY. THEY WERE REVISED TO 42+4 LATERALIZED GLENOSPHERE, REVERSE SHOULDER GLENOSPHERE LOCKING SCREW AND A 42+2.5MM CONSTRAINED HUMERAL LINER. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 24955764 ↗InjuryMar 30, 2026Detachment of Device or Device Component; Naturally Worn
AS REPORTED, APPROXIMATELY 4 YEARS AND 1 MONTH POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO POLY DISASSOCIATION. METAL ON METAL WEAR AND DEBRIS WAS FOUND DURING THE REVISION. THE POLY WAS RECALLED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Pain
MAUDE report 24712298 ↗InjuryMar 17, 2026Migration
IT WAS REPORTED THAT A FEMALE PATIENT, WHO HAD UNDERGONE A CONVERSION FROM AN ANATOMIC TO A REVERSE SHOULDER ON THE LEFT SIDE 4 WEEKS PRIOR, HAD A DISLODGED PROSTHESIS. DURING THE PRIOR CONVERSION, IT WAS NOTED THAT THERE WAS A SUBSTANTIAL DEFECT IN THE GLENOID THAT WAS ADDRESSED WITH ALLOGRAFT PACKING. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE SENT TO THE HOSPITAL¿S BIO ENGINEERING DEPARTMENT FOR ANALYSIS AND REPORTING. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 24623843 ↗InjuryMar 17, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A LEFT TSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT REPORTEDLY FELL AND DISLOCATED THEIR SHOULDER WHICH WAS REDUCED PREVIOUSLY. THE PATIENT CONTINUED TO REPORT PAIN/DISCOMFORT. THE SURGEON OBSERVED THAT THE POLYETHYLENE LINER HAD DISSOCIATED FROM THE HUMERAL TRAY. THE TRAY & LINER COMPONENTS WERE REVISED WITH A NEW TORQUE SCREW. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE NOT MADE AVAILABLE. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS.
Patient problems: Joint Dislocation
MAUDE report 24622510 ↗InjuryFeb 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISASSOCIATION OF THE HUMERAL LINER FROM THE HUMERAL TRAY. AS A RESULT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION SURGERY APPROXIMATELY 5 YEARS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Pain
MAUDE report 24327019 ↗InjuryJan 15, 2026Detachment of Device or Device Component
AS REPORTED, APPROXIMATELY 8 YEARS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO A DISASSOCIATED 42+0 LINER. THE PATIENT WAS REVISED TO A 42+2.5 CONSTRAINED LINER AND FROM A 42 GLENOSPHERE TO A 42+4. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Insufficient Information
MAUDE report 24078532 ↗InjuryJan 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO POLY DISASSOCIATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Insufficient Information
MAUDE report 24009432 ↗InjuryDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED INSTABILITY WHILE MOVING A LAWN MOWER. AS A RESULT, THEY WERE REVISED DUE TO DISASSOCIATION OF THE POLYETHYLENE. THE SURGEON REVISED THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW. THE OUTCOME IS CONSIDERED RESOLVED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Joint Laxity
MAUDE report 23907302 ↗InjuryDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, APPROXIMATELY 2 YEARS AND 7 MONTHS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO POLY DISASSOCIATION. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Pain
MAUDE report 23907212 ↗InjuryNov 14, 2025Naturally Worn; Naturally Worn
AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA. THE PATIENT'S SHOULDER WAS DISLOCATING ON AND OFF; NO FALL OR ANY TRAUMA WAS DONE TO THE SHOULDER. THE PATIENT WAS REVISED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Joint Dislocation
MAUDE report 23556180 ↗InjuryOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TSA, THE 77 Y/O MALE PATIENT EXPERIENCED POLY DISASSOCIATED FROM UNKNOWN CAUSE. IMPLANTS WERE REMOVED AND REVISED WITH NEW COMPONENTS. THE PATIENT WAS STABLE AT CONCLUSION OF CASE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.
Patient problems: Insufficient Information
MAUDE report 23390130 ↗InjurySep 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
APPROXIMATELY 3 YEAR(S), 4 MONTH(S) AND 20 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. SUBJECT NOTED PAIN WHEN REACHING. X-RAY SHOWED POLY DISASSOCIATION. THE PATIENT UNDERWENT STANDARD REVERSE WITH PRESERVE STEM REVISION, IN WHICH THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW WERE REMOVED. THE OUTCOME IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE.
Patient problems: Pain
MAUDE report 23076370 ↗InjurySep 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND ATRAUMATIC DISASSOCIATION OF THE HUMERAL LINER AND HUMERAL TRAY. AS A RESULT, THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER INITIAL IMPLANTATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Pain
MAUDE report 23009686 ↗InjurySep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED EXPERIENCING A CLUNK WHEN WORKING OUT. IT WAS DISCOVERED THAT THE PATIENT'S POLYETHYLENE LINER HAD DISASSOCIATED FROM THE TRAY. AS A RESULT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION APPROXIMATELY 8 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22978052 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K063569. One submission often covers many models, so check the product and lot details in each record.
- Z-2561-2025 · Aug 15, 2025 · Open, ClassifiedExactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/
- Z-1423-2024 · Mar 6, 2024 · Open, ClassifiedExactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
- Z-1419-2024 · Mar 6, 2024 · Open, ClassifiedExactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
- Z-1422-2024 · Mar 6, 2024 · Open, ClassifiedExactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
- Z-1424-2024 · Mar 6, 2024 · Open, ClassifiedExactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
- Z-1418-2024 · Mar 6, 2024 · Open, ClassifiedExactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
- Z-1425-2024 · Mar 6, 2024 · Open, ClassifiedExactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
- Z-0579-2024 · Nov 21, 2023 · Open, ClassifiedExactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00,
- Z-3019-2020 · Aug 24, 2020 · TerminatedEquinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
- Z-3020-2020 · Aug 24, 2020 · TerminatedEquinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
- Z-0012-2019 · Aug 21, 2018 · Open, ClassifiedEquinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
- Z-0900-2017 · Oct 25, 2016 · TerminatedEquinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
- Z-2117-2012 · Jun 15, 2012 · TerminatedEquinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
- Equinoxe 320-38-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.