DJO SURGICAL 315-0B-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912113946), received between Aug 25, 2017 and Nov 24, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K140830); 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.

• InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - TIBIAL LOOSENING DUE TO FALL.

  Patient problems: Fall; Joint Laxity

  MAUDE report 18204843 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO LOOSE TIBIA.

  Patient problems: Joint Laxity

  MAUDE report 15564018 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem

  SECOND REVISION - DUE TO UNKNOWN REASONS.

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

  MAUDE report 11398910 ↗
• InjuryAug 25, 2017Loose or Intermittent Connection

  REVISION SURGERY - DUE TO LOOSE TIBIA.

  Patient problems: No Information

  MAUDE report 6821815 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140830. One submission often covers many models, so check the product and lot details in each record.

• Z-0165-2016 · Sep 16, 2015 · Terminated
  Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.