Reported Jan 1, 2014 · Terminated
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854,…
Smith & Nephew Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew Inc · 1450 E. Brooks Rd · Memphis, TN · 38116
Is this the product you have?
- 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
- Lot codes and dates
- Batch No. 12BM04836
- Amount recalled
- 38 units
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.
This product could cause temporary or reversible health problems — stop using it.
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