DJO SURGICAL 343-13-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912172318), received between Oct 1, 2016 and Dec 29, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18422507 ↗
• InjuryAug 11, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT FELL AND CRACKED FEMUR.

  Patient problems: Fall

  MAUDE report 15210935 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15157185 ↗
• InjuryAug 3, 2021Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT STOOD UP TOO EARLY FOLLOWING SURGERY AND FRACTURED DISTAL FEMUR. SURGEON PERFORMED REVISION SURGERY WHERE HE KEPT ORIGINAL DJO FEMUR, PATELLA, AND TIBIA; PLACED A ROD AND SWAPPED THE POLY LINER.

  Patient problems: Insufficient Information

  MAUDE report 12271530 ↗
• InjuryNov 26, 2019Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO KNEE WAS UNBALANCED BECAUSE OF INSERT.

  Patient problems: No Information

  MAUDE report 9379465 ↗
• InjuryOct 1, 2016Sticking

  REVISION SURGERY - DUE TO THE PATIENT'S KNEE BEING TIGHT, THE SURGEON DID MORE RELEASE OF SOFT TISSUE.

  Patient problems: No Code Available

  MAUDE report 5992733 ↗

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-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.
• 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