Z-0864-2007

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156

Name: Z-0864-2007 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156
Creator: Smith & Nephew Inc
Published: 2007-03-13
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2007-03-13 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew Inc began a recall of Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156 on 2007-03-13. The reason FDA records is "The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0864-2007
Status: Terminated
Initiated: 2007-03-13
Posted: 2007-06-07
Terminated: 2011-10-28
Recalling firm: Smith & Nephew, Inc.
Product: Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Lot Numbers: 64597, 65004, 57078

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)