Reported Jul 27, 2022 · Completed

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during…

Aesculap Implant Systems LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aesculap Implant Systems LLC · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217

Is this the product you have?

  • ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Lot codes and dates
  • UDI-DI (GTIN)04046963419639
Amount recalled
67

This recall covers 14 products

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

Where it was sold

Why it was recalled

Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.