Reported May 18, 2016 · Terminated

Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

Stanmore Implants Worldwide Ltd.

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: Stanmore Implants Worldwide Ltd. · 210 Centennial Avenue Centennial Park · Borehamwood, N/A · N/A

Is this the product you have?

  • Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Lot codes and dates
  • Device IdentifierPIN 19960
  • Lot19960
Amount recalled
1

Where it was sold

Why it was recalled

Incorrect component used to manufacture distal femoral replacement.

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

Notice updated Jan 26, 2017 · Data as of Sep 19, 6:02 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.