Exactech 148-28-93Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862027832), received between Jul 21, 2023 and Jul 21, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K050398, K060107); 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.

• InjuryJul 21, 2023Naturally Worn; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT, HAD AN INITIAL RIGHT HIP ARTHROPLASTY 0N (B)(6), 2010 AND THEN THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6), 2017, APPROXIMATELY 7 YEARS, 3 MONTHS POST IMPLANT. THE PATIENT COMPLAINS OF PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED MOBILITY AND QUALITY OF LIFE AND NECESSITATED A REVISION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Muscle Weakness/Atrophy; Pain

  MAUDE report 17371502 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050398, K060107. One submission often covers many models, so check the product and lot details in each record.

• Z-2250-2021 · Jun 29, 2021 · Completed
  Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
• Z-2251-2021 · Jun 29, 2021 · Completed
  Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.