Recalls / —

—#55398

Product

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component.

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 may not reflect the correct size of the acetabular cup.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm

Smith & Nephew Inc

Address

1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern

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

Timeline

Recall initiated

2007-07-12

Posted by FDA

2007-10-25

Terminated

2010-02-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #55398. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.