DJO SURGICAL 343-10-766Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912171977), received between Jun 11, 2018 and Oct 14, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K160342); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - SWITCHED FROM PS INSERT TO VVC.

  Patient problems: Insufficient Information

  MAUDE report 17936626 ↗
• InjuryApr 1, 2022Unstable

  REVISION SURGERY - DUE TO INSTABILITY. REMOVED 10MM POLY AND IMPLANTED 13MM POLY.

  Patient problems: Joint Laxity

  MAUDE report 13979564 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  SECOND REVISION SURGERY - INFECTED TOTAL KNEE, SO TOOK THE POLY OUT AND WASHED KNEE THEN REPLACED THE POLY WITH A NEW ONE.

  Patient problems: Unspecified Infection

  MAUDE report 11178734 ↗
• InjuryJun 11, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO A BEARING SWAP.

  Patient problems: No Code Available

  MAUDE report 7588438 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160342. One submission often covers many models, so check the product and lot details in each record.

• Z-0042-2018 · Sep 15, 2017 · Terminated
  EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHM
• Z-0041-2018 · Sep 15, 2017 · Terminated
  EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene
• Z-1139-2017 · Jan 10, 2017 · Terminated
  Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to m
• Z-0766-2017 · Sep 19, 2016 · Terminated
  Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
• Z-0325-2017 · Sep 19, 2016 · Terminated
  Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.