DJO SURGICAL 343-12-709Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912172257), received between Oct 18, 2018 and Apr 22, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21886959 ↗
• InjuryMar 2, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY: DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13656629 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12519954 ↗
• InjuryDec 3, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10943090 ↗
• InjuryNov 19, 2019Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: No Information

  MAUDE report 9343001 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY- PATIENT FELL AND WOUND SPLIT OPEN. SO, DID A WASH OUT.

  Patient problems: Fall

  MAUDE report 8952382 ↗
• InjuryJun 14, 2019Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8701878 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT BEING INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 7981231 ↗

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-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-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-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.