DJO SURGICAL 292-09-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912112321), received between Jan 8, 2016 and Jan 29, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT GETTING A PNEUMONIA INFECTION AND THE SURGEON DID A POLY SWAP. THE ONLY THING THAT WAS CHANGED OUT WAS THE POLY.

  Patient problems: Pneumonia; Unspecified Infection

  MAUDE report 7225897 ↗
• InjuryMar 7, 2016Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT FALLING AND HURTING HER KNEE. THE SURGEON WENT IN TO TAKE CARE OF SOME BLEEDING AND UPSIZED THE POLY FROM A 9MM TO 13MM FOR INSTABILITY AFTER THE FALL.

  Patient problems: Fall

  MAUDE report 5484269 ↗
• InjuryJan 8, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO SOFT TISSUE.

  Patient problems: No Code Available

  MAUDE report 5354106 ↗

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-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.
• 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-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-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.