Class 2 Device Recall BHR Acetabular Cup W/ Impactor

Date Initiated by Firm	March 13, 2007
Date Posted	June 07, 2007
Recall Status¹	Terminated ³ on October 28, 2011
Recall Number	Z-0864-2007
Recall Event ID	37782
PMA Number	P040033
Product Classification	hip prosthesis - Product Code LXH
Product	Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156
Code Information	Lot Numbers: 64597, 65004, 57078
Recalling Firm/ Manufacturer	Smith & Nephew Inc 1450 E Brooks Rd Memphis TN 38116-1804
For Additional Information Contact	Victor Rocha 901-399-6771
Manufacturer Reason for Recall	The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
FDA Determined Cause ²	Other
Action	The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
Quantity in Commerce	4 units
Distribution	Europe. No domestic distribution.
Total Product Life Cycle	TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. ² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. ³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.