Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component.
FDA device recall Z-0026-2008 · posted 2007-10-25 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- The carton label may not reflect the correct size of the acetabular cup.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 8 units
- Distribution
- Worldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.
- Date initiated
- 2007-07-12
- Date posted
- 2007-10-25
- Date terminated
- 2010-02-02
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.