FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component.
- Recall number
- Z-0016-2008
- Recalling firm
- Smith & Nephew Inc
- Product
- Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component.
- Status
- Terminated
- Initiated
- 2007-07-12
- Posted
- 2007-10-25
- Terminated
- 2010-02-02
- Reason
- The carton label may not reflect the correct size of the acetabular cup.
- 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
- 1 unit
- Distribution
- Worldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.
- Lot, serial or model codes
- Lot Number: 64803
- 510(k) numbers
- not on file
- PMA numbers
- ["P040033"]
- Product code
- LXH
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28