DJO SURGICAL 281-03-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912111935), received between Sep 6, 2022 and Sep 6, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO LOOSENING OF TIBIA.

  Patient problems: Joint Laxity

  MAUDE report 15365274 ↗

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-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-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-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.