Recalls / —
—#75728
Product
Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures.
- FDA product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K991026
- Affected lot / code info
- Part Number: 71740250, Lot Numbers: 08FM05400 and 08FM05400B.
Why it was recalled
Liners measuring 28 mm ID and were mismarked as 32 mm.
Root cause (FDA determination)
Process control
Action the firm took
All affected Smith & Nephew International Distributors were notified via e-mail dated November 24, 2008. In a letter titled "Urgent: Product Recall Notice - Immediate Action Required", distributors were instructed to immediately notify their accounts concerning the recall. All affected product is to be located and returned to the firm immediately. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-5441.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 1450 Brooks Rd, Memphis, Tennessee 38116
Distribution
- Distribution pattern
- International Distribution to Canada, France, Germany and Switzerland.
Timeline
- Recall initiated
- 2008-11-21
- Posted by FDA
- 2009-04-21
- Terminated
- 2011-11-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #75728. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.