DJO SURGICAL 343-11-709Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888912172134), received between Mar 26, 2021 and Jul 27, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Fracture” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Fracture

  Revision Surgery - Due to Periprosthetic Fracture.

  Patient problems: Bone Fracture(s)

  MAUDE report 50002091 ↗
• InjuryMay 12, 2026Insufficient Device Problem Information

  REVISION SURGERY DUE TO POLY SWAP

  Patient problems: Insufficient Information

  MAUDE report 25156341 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO POLY SWAP. HAD A HARD RANGE OF MOTION.

  Patient problems: Joint Dislocation; Loss of Range of Motion

  MAUDE report 20315185 ↗
• InjuryApr 3, 2024Adverse 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 19038676 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO TIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 17770196 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTIBILITY.

  Patient problems: Joint Laxity

  MAUDE report 16640415 ↗
• InjuryMay 6, 2022Unstable

  REVISION SURGERY: DUE TO INSTABILITY AND PATELLA PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14306923 ↗
• InjuryJun 29, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT BECAME INFECTED, IRRIGATION & DRAINAGE WASHOUT POLY SWAP.

  Patient problems: Unspecified Infection

  MAUDE report 12088871 ↗
• InjuryMar 26, 2021Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - PATIENT PRESENTED 1 YEAR POST-OPERATION AND SAYS THAT KNEE WAS LOOSE. WENT IN AND CHANGED POLY FROM 11MM TO 14MM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11575365 ↗

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.