DJO SURGICAL 130-03-029Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912108461), received between Apr 29, 2019 and Jun 9, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K100900); 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 18, 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.

• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO FALL LOWER BODY COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 17101193 ↗
• InjuryApr 29, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO A LOOSE PATELLA.

  Patient problems: No Information

  MAUDE report 8562073 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100900. One submission often covers many models, so check the product and lot details in each record.

• Z-0329-2018 · Dec 12, 2017 · Terminated
  EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
• Z-0328-2018 · Dec 12, 2017 · Terminated
  EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
• Z-0326-2018 · Dec 12, 2017 · Terminated
  DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
• Z-0327-2018 · Dec 12, 2017 · Terminated
  EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.