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Smith & Nephew, Inc. recalls smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, Q
Recalled September 6, 2017 · FDA recall Z-3100-2017 · Smith & Nephew
Hazard
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures. · FDA Class II
Units
402 units
Sold at
Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
Description
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Product
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
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →