DJO SURGICAL 346-14-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00190446269977), received between Dec 22, 2021 and May 7, 2026 — classified as 6 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K180930); 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.

• InjuryMay 7, 2026Unstable

  REVISION SURGERY DUE TO INSTABIITY; THE SURGEON WAS CARRYING OUT A QUAD TENDON REPAIR AND DID A POLY SWAP FOR INCREASED STABILITY. FEMALE 68

  Patient problems: Joint Laxity

  MAUDE report 25119718 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ANTERIOR KNEE PAIN.

  Patient problems: Pain

  MAUDE report 23774432 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PATELLA TENDON REPAIR. POLY SWAP.

  Patient problems: Insufficient Information

  MAUDE report 22207821 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - MDR - HYPEREXTENSION/REVISION SURGERY/ REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.

  Patient problems: Joint Dislocation

  MAUDE report 17874008 ↗
• InjuryJul 21, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT HAS INSTABILITY.

  Patient problems: Insufficient Information

  MAUDE report 15077225 ↗
• InjuryDec 22, 2021Unstable

  REVISION SURGERY - THE PATIENT FELT UNSTABLE. SHE NEEDED A POLY THICKER THAN 19MM.

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

  MAUDE report 13060331 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180930. One submission often covers many models, so check the product and lot details in each record.

• Z-1187-2023 · Dec 22, 2022 · Open, Classified
  EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22