NA 202.900Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982145192), received between Mar 20, 2023 and Mar 20, 2023 — classified as 1 injury.

5 other recalls cover devices cleared under the same FDA submission (K010321, K050110, K063049, K102694, 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.

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.

• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON NOVEMBER OF 2022, THE PATIENT UNDERWENT REVISION DUE TO SWELLLING, INFECTION(SEPSIS), PAIN AND IMPLANT FAILURE. XRAY AND ULTRASOUND CONFIRMED THAT THE HARDWARE IN HIS ANKLE HAS FAILED. THE PATIENT IS CURRENTLY TAKING BOTH ORAL AND IV ANTIBIOTICS. ON APRIL OF 2021 THE PATIENT WAS IMPLANTED WITH SYNTHES DEVICES ON LEFT ANKLE AFTER FALLING FROM A TREE. THIS REPORT IS FOR ONE (1)2.7 CORTEX SCREW SLF-TPNG T8 SD REC 40 THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16572160 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010321, K050110, K063049, K102694, K112583. 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-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