NA 02.211.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982053589), received between Feb 28, 2018 and Sep 5, 2025 — classified as 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 reports).

7 other recalls cover devices cleared under the same FDA submission (K100776, K103243); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS REQUESTING INFORMATION REGARDING ANY POTENTIAL RECALLS AND MATERIAL MAKEUP OF HER PLATE AND SCREWS DUE TO SYMPTOMS SHE IS EXPERIENCING SINCE THE IMPLANTATION IN (B)(6) 2016 FOR A BROKEN ANKLE AND TIBIA. SYMPTOMS BEGAN 9 MONTHS AFTERWARD AND INCLUDE HYPERSENSITIVITY, AN IMMUNE RESPONSE THAT HAS "MESSED UP HER SYSTEM," HIGH TITER, DISCOID LUPUS, SKIN ISSUES, BODY ACHES, FATIGUE, FEVERS, JOINT PAIN, STIFFNESS, REDNESS, AND EXTREME FATIGUE. PATIENT'S SURGEON WOULD LIKE TO PERFORM AN MRI AND POTENTIALLY REMOVE THE DEVICE.

  Patient problems: Fatigue; Fever; Hypersensitivity/Allergic reaction; Muscular Rigidity; Pain; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22985501 ↗
• MalfunctionNov 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, AN ORIF ANKLE WAS PERFORMED AT HOSPITAL AS THE PLATE FAILED TO LOCK WITH THE SCREWS IN THE ANKLE SURGERY. STAFF TRIED MULTIPLE DIFFERENT SCREWS, DRILLED ON ANGLE AND VA, TRIED A DIFFERENT PLATE, YET THE LOCKING SCREWS WOULD NOT LOCK INTO THE DISTAL CLUSTER. DUE TO THE PLATE NOT LOCKING, IT CAUSED UNNECESSARY DRILLING OF BONE AND ELONGATED TIME UNDER ANESTHESIA. THERE WAS A SURGICAL DELAY OF 1 HOUR. SURGEON SWAPPED THE PLATE OUT FOR FUNCTIONAL HARDWARE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732768 ↗
• MalfunctionNov 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED, THAT ON (B)(6) 2024. THE PATIENT WAS INVOLVED AND THE CASE WAS COMPLETED SUCCESSFULLY. THE SCREWS WERE NOT LOCKING.

  Patient problems: Insufficient Information

  MAUDE report 20675981 ↗
• MalfunctionNov 14, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PACKAGE WAS RECEIVED COMPLETELY EMPTY. THE PACKAGE DOES NOT LOOK AS IF IT WAS EVER SEALED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131343 ↗
• MalfunctionApr 16, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 2.7 VARIABLE ANGLE SCREW STAR DRIVE. THIS SCREW OCCURRED TO HAVE DAMAGED THREAD OF THE HEAD OF SCREW WHEN IT WAS LOCKING THE PLATE. THE PART OF SCREW WAS REMOVED. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNK - PLATES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 14 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748635 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE REMOVAL OF HARDWARE AND REVISION OF PATELLA WAS PERFORMED DUE TO NONUNION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15675641 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE REMOVAL OF HARDWARE AND REVISION OF PATELLA WAS PERFORMED DUE TO NONUNION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15675635 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE REMOVAL OF HARDWARE AND REVISION OF PATELLA WAS PERFORMED DUE TO NONUNION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 5 OF 7 FOR COMPLAINT: (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15675634 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON SEPTEMBER 13, REMOVAL OF HARDWARE AND REVISION OF PATELLA DUE TO NONUNION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 14 THIS IS REPORT 2 OF 3 FOR COMPLAINT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15561909 ↗
• MalfunctionSep 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE SURGEON INDICATED THAT A 2.7MM LOCKING SCREW WOULD NOT THREAD TO OR ENGAGE/LOCK INTO THE T FUSION PLATE. HE USED THE VARIABLE ANGLE (VA) CONE AND DRILLED IN APPROXIMATELY 15 DEGREES BUT HAS DIFFICULTY WITH THE SCREW LOCKING TO THE PLATE. THE PLATE WAS USED WITH NO FURTHER ISSUES. THE SURGERY WAS DELAYED FOR ONE (1) MINUTE DUE TO REPORTED EVENT. SURGERY WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421401 ↗
• InjuryAug 15, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT FUSION SURGERY ON THE FOOT AND WAS IMPLANTED WITH ONE (1) VARIABLE ANGLE- LOCKING COMPRESSION PLATE (VA-LCP) CLOVERLEAF FUSION PLATE, ONE (1) VA-LCP T-FUSION PLATE 2 HOLE HEAD, ONE(1) 4.0MM CANNULATED SCREW LONG THREAD, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 26MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 28MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 24MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 32MM, AND ONE (1) WASHER. IN LATE 2015, THE PATIENT BEGAN TO EXPERIENCE DISCOMFORT AND PAIN WHICH ATTRIBUTED TO HIS OSTEOARTHRITIS AND PREVIOUS FRACTURE. ON (B)(6) 2016, THE PAIN HAD WORSENED. X-RAYS OF THE FOOT WERE TAKEN WHICH SHOWED SEVERAL OF THE UNKNOWN SYNTHES SCREWS IMPLANTED WERE BROKEN. THE PATIENT¿S CLINIC VISITS ON (B)(6) 2016 AND (B)(6) 2017 WERE DUE TO THE PAIN FELT IN THE RIGHT ANKLE. THE PATIENT MET WITH ANOTHER SURGEON FOR A POSSIBLE REVISION, BUT THE SURGEON REFUSED TO PERFORM DUE TO THE RIS

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8898757 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF PAINFUL HARDWARE PROXIMAL ASPECT OF RIGHT ULNA. ON (B)(6) 2014, THE PATIENT SUSTAINED AN INJURY AFTER TRIPPING AND FALLING FROM A STANDING POSITION AND LANDED DIRECTLY INTO THE RIGHT ELBOW. THE PATIENT HAD THE ONSET OF PAIN AND INABILITY TO FULLY USE THE ELBOW. SUBSEQUENT X-RAYS WERE TAKEN AND REVEALED A DISPLACED, DISTRACTED OLECRANON FRACTURE, WITH A COMMINUTED RIGHT RADIAL HEAD FRACTURE. THE PATIENT ALSO COMPLAINS OF PAIN IN THE RIGHT PROXIMAL HUMERUS. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2014 WITH ONE (1) VARIABLE ANGLE ¿ LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8; STARDRIVE RECESS 14MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8; STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8; STARDRIVE RECESS 20MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8; STARDRIVE RECESS 24MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8. STARDRIVE RECESS 40MM, ONE (1) LOCKING SCREW SELF-TAPPING WITH

  Patient problems: Bone Fracture(s); Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8692233 ↗
• InjuryJun 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT, ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE EXTENDED MEDIAL DISTAL HUMERUS PLATES, ONE (1) CORTEX SCREW SELF-TAPPING 50MM, ONE (1) CORTEX SCREW SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 24MM, THREE (3) CORTEX SCREWS SELF-TAPPING 20MM, ONE (1) CORTEX SCREW SELF-TAPPING 22MM, ONE (1) CORTEX SCREW SELF-TAPPING 26MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM AND ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM. SOME SCREWS WERE BROKEN AND LEFT. OTHER SCREWS WERE LEFT IN THE BODY. IT IS UNKNOWN IF WHAT SCREWS WERE LEFT/BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. P

  Patient problems: Pain

  MAUDE report 8684317 ↗
• MalfunctionJun 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THREE (3) LOCKING SCREWS WERE NOT LOCKING IN. THE VARIABLE ANGLE DISTAL FIBULA PLATE WAS ALSO USED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SCREWS STILL IMPLANTED IN THE PATIENT. CONCOMITANT DEVICES REPORTED: 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/6 HOLES/LEFT (PART# 02.118.407, LOT# UNKNOWN, QUANTITY# 1. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8670639 ↗
• MalfunctionApr 26, 2019Break; Break

  IT WAS REPORTED THAT DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE ON (B)(6) 2019, THE THREADS OF A VARIABLE ANGLE LOCKING SCREW PEELED OFF WHEN INSERTED THROUGH PLATE. THE SCREW LOCKED INTO A PLATE AND THE SURGERY WAS CONTINUED. FRAGMENTS WERE GENERATED AND REMOVED EASILY. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8556736 ↗
• InjuryDec 10, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT A PROCEDURE. DURING THE PROCEDURE, TWO (2) LOCKING SCREWS WOULD NOT LOCK IN THE SPECIFIC SCREW HOLES OF THE PLATE. THE SURGEON HAD TO JUST LEAVE THAT HOLE WITHOUT THE LOCKING SCREWS IN IT. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THREE (3) MINUTES DELAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR ONE (1) VA LOCKING SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8147140 ↗
• InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) OLECRANON PLATE ON (B)(6) 2018, DUE TO PAIN. DURING REMOVAL OF THE PLATE, THE SCREWDRIVER WOULD NOT DISENGAGE FROM THE SCREWDRIVER HANDLE. ANOTHER SCREWDRIVER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A TEN (10) MINUTE DELAY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT WILL ADDRESS THE COMPLAINT ABOUT THE VA-LCP OLECRANON PLATE THAT WAS REMOVED DUE TO PAIN. THE SCREWDRIVER BLADE AND SCREWDRIVER HANDLE HAVE BEEN CAPTURED UNDER RELATED COMPLAINT NUMBER (B)(4). THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7753670 ↗
• MalfunctionMar 30, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT PROCEDURE FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OLECRANON FRACTURE. DURING THE PROCEDURE, A LOCKING SCREW WOULD NOT LOCK INTO THE LEFT OLECRANON PLATE. THE SURGEON TRIED TO INSERT THE SCREW IN ON POWER THEN SWITCHED TO MANUAL, BUT WAS STILL UNSUCCESSFUL. THE INTERFACE BETWEEN THE PLATE AND SCREW DID NOT LOCK INTO THE PLATE. THERE WAS A TWO-MINUTE SURGICAL DELAY TO OBTAIN ANOTHER OF THE SAME SCREW WHICH WAS INSERTED IN A DIFFERENT HOLE IN THE PLATE. THE PLATE AND TEN (10) SCREWS WERE IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS AS EXPECTED. CONCOMITANT DEVICES REPORTED: POWER SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7385137 ↗
• InjuryFeb 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING THE PLACEMENT OF A 2.7 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE FOR THE DISTAL FIBULA, ON (B)(6) 2018, THE SURGEON REPORTEDLY AFFIXED THE FIRST TWO 3.5 CORTICAL SCREWS TO THE 3-HOLE PLATE WITHOUT ISSUE; THE SECOND SCREW BEING PLACED IN THE DISTAL PART OF THE PLATE. WHILE PLACING THE THIRD SCREW, IT WOULD NOT LOCK INTO THE DISTAL HOLE OF THE PLATE AS EXPECTED. THE SCREW SEEMED TO DANCE AROUND THE HOLE IN THE PLATE. THE SURGEON PROCEEDED TO ATTEMPT FIXATION OF THE THIRD SCREW IN ANOTHER DISTAL HOLE BUT THE SCREW FAILED TO LOCK IN THE PLATE AND STILL SEEMED TO DANCE AROUND WITHOUT BEING LOCKED IN TO THE PLATE AS EXPECTED. THE SURGEON TRIED SEVERAL TIMES TO PLACE THE SCREW WITHOUT ANY SUCCESS. THE SURGEON PROCEEDED TO REMOVE THE PLATE WITH SCREWS. IT WAS SUGGESTED BY THE SURGICAL TECHNICIAN THAT THE SURGEON USE THE SAME PLATE AND SCREWS WHILE USING A LONGER METAPHYSEAL SCREW IN THE MIDDLE OF THE PLATE (AS THE BONE MAY BE MORE POROUS AND WEAKER POSSIBLY DUE TO THE PATIENT¿S OSTEOPOROTIC BONE). IN THE END, THE SURGEON CHOSE TO PLACE A FIVE HOLE PLATE; PRE-DRILLING 2 ADDITIONAL HOLES FOR THE PLACEMENT OF THE SCREWS. THIS PLATE WAS REPORTEDLY PREVIOUSLY TESTE

  Patient problems: No Code Available

  MAUDE report 7303354 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100776, K103243. One submission often covers many models, so check the product and lot details in each record.

• Z-0879-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0881-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0880-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0883-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0882-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag