NA 101-05-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862010667), received between Nov 2, 2020 and Nov 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K141797, K182346, K896601, K993082); 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.

• InjuryNov 2, 2020Break; Break

  AS REPORTED, DURING A PROCEDURE ON THIS (B)(6), THE DRILL BIT BROKE WHEN DRILLING THE LEFT ACETABULAR SCREW. THERE WERE NO X-RAYS TAKEN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10774285 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141797, K182346, K896601, K993082. One submission often covers many models, so check the product and lot details in each record.

• Z-1734-2022 · Aug 11, 2022 · Open, Classified
  GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 13
• Z-1031-2017 · Nov 7, 2016 · Terminated
  AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.