DJO SURGICAL 321-10-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912114752), received between Mar 21, 2016 and Mar 21, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination” (1 report).

1 other recall cover devices cleared under the same FDA submission (K941306); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2016Contamination

  REVISION SURGERY - DUE TO AN INFECTION; THE SURGEON REMOVED ALL OF THE IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 5514750 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K941306. One submission often covers many models, so check the product and lot details in each record.

• Z-2466-2008 · Aug 4, 2008 · Terminated
  FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of t