NA 04.100.023Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982099488), received between Jul 31, 2023 and Jul 31, 2023 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K050110, K071264); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 27-MAY-2022 IN WHICH THE PRODUCTS IN QUESTION WERE IMPLANTED. THE PATIENT HAS BEEN PRESENTING WITH A REACTION AT THE SITE OF THE PROCEDURE FOR OVER 1 YEAR. PRODUCTS HAVE NOT BEEN EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR A 2.4/2.7MM TI LOCKING TALUS PLATE. THIS IS REPORT 2 OF 5 FOR (B)(6).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17424258 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 IN WHICH THE PRODUCTS IN QUESTION WERE IMPLANTED. THE PATIENT HAS BEEN PRESENTING WITH A REACTION AT THE SITE OF THE PROCEDURE FOR OVER 1 YEAR. PRODUCTS HAVE NOT BEEN EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR A 2.4/2.7MM TI LOCKING TALUS PLATE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17424255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050110, K071264. 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