Reported Sep 6, 2017 · Terminated
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE,…
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 · 38116-1804
Is this the product you have?
- smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE
- QTY(1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument
- Lot codes and dates
- Lot Numbers
A57835A57837A58509A59084A59446A59547A60948
- Lot Numbers
- Amount recalled
- 402 units
Where it was sold
- Nationwide
Why it was recalled
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
This product could cause temporary or reversible health problems — stop using it.
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