Medical Device Recall: Z-0016-2008

FDA Recalls dataset · Firm: Smith & Nephew Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2007-07-12 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0016-2008.

Recall Res Number
Z-0016-2008
Recalling Firm / Manufacturer
Smith & Nephew Inc
FEI Number
1020279
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2007-07-12
Date Posted
2007-10-25
Date Terminated
2010-02-02
Product Code
LXH
Event Number
39402
Product Quantity
1 unit
Product Description Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component.
Reason for Recall The carton label may not reflect the correct size of the acetabular cup.
Action Details 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.
Distribution Pattern Worldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.
Code Information / Serial Numbers Lot Number: 64803

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.