NA 101-05-46Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862010704), received between Sep 25, 2019 and Sep 25, 2019 — classified as 1 malfunction.

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.

• MalfunctionSep 25, 2019Break

  AFTER DRILLING FOR A SCREW, DRILL BIT STAYED IN BONE AS A RESULT OF THE END OF THE DRILL HANDLE BREAKING. ALL PIECES WERE RETRIEVED, NO DELAY TO SURGERY AND NO ADVERSE EFFECTS TO THE PATIENT. PATIENT LEFT THE ROOM STABLE. NOTE: THIS COMPLAINT WAS NEVER EMAIL OR PHONE IN. COMPLAINTS WERE NOTIFIED UPON RECEIVING OF DEVICE FROM COC.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9120538 ↗

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.