FDA recall Z-3100-2017

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

Reason for recall

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

Distribution

Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.

Key facts

Status

Terminated

Initiation date

2017-07-24

Report date

2017-09-06

Termination date

2020-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3100-2017