Recalls / —
—#55403
Product
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant component.
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- PMA numbers
- P040033
- Affected lot / code info
- Lot Numbers: 64797, 64798, 64846, 65084, 67553, 67555, 67557, 67871, 67388, 67589, 67706
Why it was recalled
The carton label may not reflect the correct size of the acetabular cup.
Root cause (FDA determination)
Packaging process control
Action the firm took
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.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- Worldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.
Timeline
- Recall initiated
- 2007-07-12
- Posted by FDA
- 2007-10-25
- Terminated
- 2010-02-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #55403. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.