Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 50 mm cup Ref.: 74120150
FDA Recall Z-0863-2007 · Posted 2007-06-07
Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeLXH
Date Initiated2007-03-13
Date Terminated2011-10-28
Product Quantity1 unit
Reason for Recall
The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
Firm Action
The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
Root Cause
Other
Distribution Pattern
Europe. No domestic distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.