Z-0027-2008

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component

Name: Z-0027-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component
Creator: Smith & Nephew Inc
Published: 2007-07-12
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2007-07-12 / Terminated / root cause: packaging

FDA source

Smith & Nephew Inc began a recall of Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component on 2007-07-12. The reason FDA records is "The carton label may not reflect the correct size of the acetabular cup". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0027-2008
Status: Terminated
Initiated: 2007-07-12
Posted: 2007-10-25
Terminated: 2010-02-02
Recalling firm: Smith & Nephew, Inc.
Product: Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The carton label may not reflect the correct size of the acetabular cup.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 6 units
Distribution: Worldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.
Product codes and lots: Lot Numbers: 64178, 65670, 66424, 66802

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)