NA 202.255Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982144171), received between Aug 20, 2018 and Aug 20, 2018 — classified as 1 injury.

5 other recalls cover devices cleared under the same FDA submission (K033995, K050110, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OR AROUND (B)(6) 2016 SURGEON PERFORMED A CORRECTION OF NON UNION OF LEFT SUPRACONDYLAR HUMERUS FRACTURE. DEPUY SYNTHES HARDWARE WAS EXPLANTED AND BONE GRAFT WAS IMPLANTED. SURGEON ALSO PERFORMED NEUROLYSIS OF THE LEFT ULNAR NERVE. DUE TO DATABASE LIMITATIONS, EIGHT (8) ADDITIONAL DEVICES ARE CAPTURED IN (B)(4). THIS REPORT ADDRESSES DEVICES IDENTIFIED IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018. THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7799279 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033995, K050110, 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
• Z-2278-2013 · Mar 8, 2013 · Terminated
  Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults