Recall Z-1623-2016— Stanmore Implants Worldwide Ltd.

Name: FDA recall Z-1623-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-12

Class II · Terminated

Class II FDA medical device recall by Stanmore Implants Worldwide Ltd., initiated 2016-04-12, terminated 2017-01-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960. Reason: Incorrect component used to manufacture distal femoral replacement..

Recalling firm: Stanmore Implants Worldwide Ltd.
Classification: Class II
Status: Terminated
Initiated: 2016-04-12
Terminated: 2017-01-26
Firm location: Borehamwood, N/A, United Kingdom

Product description

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

Reason for recall

Incorrect component used to manufacture distal femoral replacement.

Data sourced from openFDA. This site is unofficial and independent of the FDA.