Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component.
FDA Recall Z-0029-2008 · Posted 2007-10-25
Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeLXH
Date Initiated2007-07-12
Date Terminated2010-02-02
Product Quantity2 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.