Exactech 142-28-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862026781), received between Jun 22, 2021 and Jun 22, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K041906); 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.

• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH HIP REPLACEMENT STUDY, APPROXIMATELY TWO MONTHS POST THA, THE (B)(6) Y/O FEMALE PATIENT EXPERIENCED LEFT HIP PROSTHESIS DISLOCATION. THE EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. PATIENT WAS DISCHARGED TO EXTENDED CARE FACILITY WITH A WALKER 3 DAYS POSTOP. DEVICE WILL NOT RETURN DUE TO CLINICAL STUDY POLICY.

  Patient problems: Joint Dislocation

  MAUDE report 12046233 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041906. One submission often covers many models, so check the product and lot details in each record.

• Z-1727-2022 · Aug 11, 2022 · Open, Classified
  GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DE