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NA 201.764Recalls & reported problems

Synthes GmbH · 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Synthes cortex screw is an implantable screw used to hold bone in place. The 37 reports mostly describe screws that would not fit into predrilled holes or were hard to advance into bone, with surgeons switching to another screw to complete the case. There were no deaths and no injuries. No recalls name this device.

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
37
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10886982142757), received between Oct 29, 2018 and Sep 19, 2024 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (28 reports).

10 other recalls cover devices cleared under the same FDA submission (K002271, K063049, K102694, K103243, K112583); 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device-Device Incompatibility28
  • Difficult to Advance7
  • Material Deformation2
  • Material Twisted/Bent2
  • Appropriate Device Problem Term/Code Not Available1
  • No Apparent Adverse Event1

Patient problems

  • No Clinical Signs, Symptoms or Conditions30
  • No Consequences Or Impact To Patient5
  • Insufficient Information2

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 19, 2024Difficult to Advance; Difficult to Advance

    ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

    Patient problems: Insufficient Information

    MAUDE report 20255123 ↗
  • MalfunctionSep 19, 2024Difficult to Advance; Difficult to Advance

    IT WAS REPORTED THAT ON UNKNOWN DATE THE 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 14 ARE NOT CAPPING WHEN BEING INSERTED.

    Patient problems: Insufficient Information

    MAUDE report 20255099 ↗
  • MalfunctionDec 21, 2023Difficult to Advance; Appropriate Device Problem Term/Code Not Available; Difficult to Advance; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT ON NOVEMBER 29, 2023, A 14MM X 2.4 CORTEX SCREWS WOULD NOT FIT INTO PREDRILLED HOLE DURING A DISTAL RADIUS FIXATION CASE WITHOUT SUBSTANTIAL DIFFICULTY. SIGNIFICANT FORCE WAS NEEDED TO GET THE SCREW TO BEGIN THREADING INTO BONE. SURGEON AND RESIDENT COMPLAINED. CASE WAS ABLE TO PROCEED SUCCESSFULLY. SURGEON USED ANOTHER SCREW AND IMPACT TO BEGIN SCREW INSERTION. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18371197 ↗
  • MalfunctionAug 23, 2023Difficult to Advance; Difficult to Advance

    IT WAS REPORTED THAT ON (B)(6) 2023 DURING ORIF OF RADIUS AND ULNA, WHILE INSERTING A 14 MM 2.4MM CORTEX SCREW IN A PILOT HOLE, THE SCREW WOULD NOT INSERT INTO THE BONE. THE SCREW WAS ATTEMPTED TO BE INSERTED WITH BOTH A POWER SCREW DRIVER AND A HAND SCREW DRIVER BUT WOULD NOT ADVANCE. THIS HAPPENED WITH 2 SCREWS AND IT APPEARED TO BE THAT THE SCREWS WERE NOT SELF TAPPING. SURGEON TRIED ANOTHER 14MM 2.4MM CORTEX SCREW UNTIL ONE ADVANCED INTO THE BONE. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVERS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) UNK - POWERED DRIVERS/HANDPIECES (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 14 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17607856 ↗
  • MalfunctionAug 23, 2023Difficult to Advance; Difficult to Advance

    IT WAS REPORTED THAT ON (B)(6), 2023 DURING ORIF OF RADIUS AND ULNA, WHILE INSERTING A 14 MM 2.4MM CORTEX SCREW IN A PILOT HOLE, THE SCREW WOULD NOT INSERT INTO THE BONE. THE SCREW WAS ATTEMPTED TO BE INSERTED WITH BOTH A POWER SCREW DRIVER AND A HAND SCREW DRIVER BUT WOULD NOT ADVANCE. THIS HAPPENED WITH 2 SCREWS AND IT APPEARED TO BE THAT THE SCREWS WERE NOT SELF TAPPING. SURGEON TRIED ANOTHER 14MM 2.4MM CORTEX SCREW UNTIL ONE ADVANCED INTO THE BONE. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVERS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNK - POWERED DRIVERS/HANDPIECES (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 14 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17605445 ↗
  • MalfunctionAug 18, 2023Difficult to Advance; Material Deformation; No Apparent Adverse Event; Difficult to Advance; Material Deformation; No Apparent Adverse Event

    IT WAS REPORTED THAT ON (B)(6), 2023, THE SURGEON STATED THAT A 2.4MM X 14MM CORTEX SCREW WOULD NOT ADVANCE INTO THE BONE. UPON INSPECTION, IT APPEARS THAT THE SCREW HEAD AND SELF-TAPPING CUTOUT ON THE SCREW TIP IS ABNORMAL. SURGEON DESCRIBED THAT IT IS A FLAW IN THE SCREW. SCREW WAS REMOVED AND REPLACED WITH ANOTHER SCREW OF THE SAME SIZE AND TYPE. PATIENT HAS HISTORY OF EPILEPSY. THERE WAS A SURGICAL DELAY OF 3 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 14. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17572647 ↗
  • MalfunctionAug 18, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

    IT WAS REPORTED THAT ON (B)(6), 2023, THE SURGEON STATED THAT A 2.4MM X 14MM CORTEX SCREW WOULD NOT ADVANCE INTO THE BONE. UPON INSPECTION, IT APPEARS THAT THE SCREW HEAD AND SELF-TAPPING CUTOUT ON THE SCREW TIP IS ABNORMAL. SURGEON DESCRIBED THAT IT IS A FLAW IN THE SCREW. SCREW WAS REMOVED AND REPLACED WITH ANOTHER SCREW OF THE SAME SIZE AND TYPE. PATIENT HAS HISTORY OF EPILEPSY. THERE WAS A SURGICAL DELAY OF 3 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 14. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17572644 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12557646 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12557590 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12557582 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12557580 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12557573 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A PROCEDURE FOR DISTAL RADIUS. THE 2.4MM CORTEX SCREWS IN THE VA DISTAL RADIUS SET DON'T FIT THROUGH THE DISTAL DRILL GUIDES AND THE SCREW INSTEAD LOCKS THE GUIDE DOWN TO THE BONE. WHILE EXAMINING THE SCREW HEAD IT¿S VISIBLE TO SEE A SLIGHT DIFFERENCE BETWEEN ONES THAT FIT AND THE ONES THAT DON'T. THE SURGEON TRIED TO USE DISTAL DRILL GUIDE BLOCKS AND THE SCREW WOULDN'T FIT THROUGH BLOCK WHICH LOCKS THE PLATE TO THE RADIUS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY AND NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNK - PLATES: VA-LCP DISTAL RADIUS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 17 OF 20 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12557569 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12557565 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12557551 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12557532 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT FOR A SURGICAL PROCEDURE FOR DISTAL RADIUS. THE 2.4 CORTEX SCREWS IN THE VA DISTAL RADIUS SET DON'T FIT THROUGH THE DISTAL DRILL GUIDES . THE SCREW INSTEAD LOCKS THE GUIDE DOWN TO THE BONE. TRIED TO USE DISTAL DRILL GUIDE BLOCKS AND THE SCREW WOULDN'T FIT THROUGH BLOCK AND LOCKED THE PLATE TO THE RADIUS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - PLATES: VA-LCP DISTAL RADIUS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES (26) DEVICES. THIS REPORT IS FOR (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS REPORT IS 3 OF 6 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12556332 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT FOR A SURGICAL PROCEDURE FOR DISTAL RADIUS. THE 2.4 CORTEX SCREWS IN THE VA DISTAL RADIUS SET DON¿T FIT THROUGH THE DISTAL DRILL GUIDES . THE SCREW INSTEAD LOCKS THE GUIDE DOWN TO THE BONE. TRIED TO USE DISTAL DRILL GUIDE BLOCKS AND THE SCREW WOULDN¿T FIT THROUGH BLOCK AND LOCKED THE PLATE TO THE RADIUS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - PLATES: VA-LCP DISTAL RADIUS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWENTY-SIX(26) DEVICES. THIS REPORT IS FOR (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS REPORT IS 4 OF 6 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12556321 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT FOR A SURGICAL PROCEDURE FOR DISTAL RADIUS. THE 2.4 CORTEX SCREWS IN THE VA DISTAL RADIUS SET DON'T FIT THROUGH THE DISTAL DRILL GUIDES . THE SCREW INSTEAD LOCKS THE GUIDE DOWN TO THE BONE. TRIED TO USE DISTAL DRILL GUIDE BLOCKS AND THE SCREW WOULDN'T FIT THROUGH BLOCK AND LOCKED THE PLATE TO THE RADIUS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - PLATES: VA-LCP DISTAL RADIUS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES (26) DEVICES. THIS REPORT IS FOR (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS REPORT IS 5 OF 6 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12556313 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT FOR A SURGICAL PROCEDURE FOR DISTAL RADIUS. THE 2.4 CORTEX SCREWS IN THE VA DISTAL RADIUS SET DON¿T FIT THROUGH THE DISTAL DRILL GUIDES . THE SCREW INSTEAD LOCKS THE GUIDE DOWN TO THE BONE. TRIED TO USE DISTAL DRILL GUIDE BLOCKS AND THE SCREW WOULDN¿T FIT THROUGH BLOCK AND LOCKED THE PLATE TO THE RADIUS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNK - PLATES: VA-LCP DISTAL RADIUS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWENTY-SIX (26) DEVICES. THIS REPORT IS FOR (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS REPORT IS 6 OF 6 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12556296 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A PROCEDURE FOR DISTAL RADIUS. THE 2.4MM CORTEX SCREWS IN THE VA DISTAL RADIUS SET DON'T FIT THROUGH THE DISTAL DRILL GUIDES AND THE SCREW INSTEAD LOCKS THE GUIDE DOWN TO THE BONE. WHILE EXAMINING THE SCREW HEAD IT¿S VISIBLE TO SEE A SLIGHT DIFFERENCE BETWEEN ONES THAT FIT AND THE ONES THAT DON'T. THE SURGEON TRIED TO USE DISTAL DRILL GUIDE BLOCKS AND THE SCREW WOULDN'T FIT THROUGH BLOCK WHICH LOCKS THE PLATE TO THE RADIUS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY AND NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNK - PLATES: VA-LCP DISTAL RADIUS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 6 OF 20 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12555845 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12555827 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A PROCEDURE FOR DISTAL RADIUS. THE 2.4MM CORTEX SCREWS IN THE VA DISTAL RADIUS SET DON'T FIT THROUGH THE DISTAL DRILL GUIDES AND THE SCREW INSTEAD LOCKS THE GUIDE DOWN TO THE BONE. WHILE EXAMINING THE SCREW HEAD IT¿S VISIBLE TO SEE A SLIGHT DIFFERENCE BETWEEN ONES THAT FIT AND THE ONES THAT DON'T. THE SURGEON TRIED TO USE DISTAL DRILL GUIDE BLOCKS AND THE SCREW WOULDN'T FIT THROUGH BLOCK WHICH LOCKS THE PLATE TO THE RADIUS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY AND NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNK - PLATES: VA-LCP DISTAL RADIUS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 7 OF 20 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12555824 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12555812 ↗
  • MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

    THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12555809 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002271, K063049, K102694, K103243, K112583. One submission often covers many models, so check the product and lot details in each record.

  • 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-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-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-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-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-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
  • Z-0167-2016 · Oct 6, 2015 · Terminated
    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
  • Z-0380-2014 · Jul 31, 2013 · Terminated
    2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen
  • Z-0956-2013 · Jan 11, 2013 · Terminated
    Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor

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