Recalls / —

—#51517

Product

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146

FDA product code

LXH — Orthopedic Manual Surgical Instrument

Device class

Class 1

Medical specialty

Orthopedic

PMA numbers

P040033

Affected lot / code info

Lot Number: 64803

Why it was recalled

The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.

Root cause (FDA determination)

Other

Action the firm took

The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.

Recalling firm

Firm

Smith & Nephew Inc

Address

1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern

Europe. No domestic distribution.

Timeline

Recall initiated

2007-03-13

Posted by FDA

2007-06-07

Terminated

2011-10-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #51517. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.