NA 201.357.97Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982141828), received between May 24, 2019 and May 24, 2019 — classified as 4 injuries.

4 other recalls cover devices cleared under the same FDA submission (K063049); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 17 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8641487 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 16 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8641190 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 5 OF 10 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 15 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8641132 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 11 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8640713 ↗

Recalls under the same FDA submission

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

• 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