Recalls / —
—#124594
Product
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.
- FDA product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K012787
- Affected lot / code info
- Batch No. 12BM04836
Why it was recalled
One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.
Root cause (FDA determination)
Other
Action the firm took
All affected sales staff was notified of problem and the recall via email on 11/25/2013. There were no US hospitals affected by this recall.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 1450 E. Brooks Rd, Memphis, Tennessee 38116
Distribution
- Distribution pattern
- Distributed in China and Spain.
Timeline
- Recall initiated
- 2013-11-25
- Posted by FDA
- 2013-12-26
- Terminated
- 2017-02-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #124594. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.