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Terminated

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

FDA Recall Z-1623-2016 · Posted 2016-05-09

Recalling FirmStanmore Implants Worldwide Ltd.
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-04-12
Date Terminated2017-01-26
Product Quantity1

Reason for Recall

Incorrect component used to manufacture distal femoral replacement.

Firm Action

A notification was sent to the prescribing physician on 04/12/2016.

Root Cause

Mixed-up of materials/components

Distribution Pattern

US distribution to OH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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