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Terminated

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component.

FDA Recall Z-0026-2008 · Posted 2007-10-25

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeLXH
Date Initiated2007-07-12
Date Terminated2010-02-02
Product Quantity8 units

Reason for Recall

The carton label may not reflect the correct size of the acetabular cup.

Firm Action

The consignees were notified of the problem and the recall by initially by telephone on 07/12/2007 and followed by a letter dated 07/24/2007.

Root Cause

Packaging process control

Distribution Pattern

Worldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.

Official Source

View FDA Recall →

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

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