PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 6, 2017 Initiated: July 24, 2017 #Z-3100-2017

Product Description

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

Reason for Recall

The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
402 units
Distribution
Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Smith & Nephew, Inc.. Units affected: 402 units.
Why was this product recalled? ▼
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2017. Severity: Moderate. Recall number: Z-3100-2017.

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