FDAFDA · Food and drugs·Recall number Z-3100-2017
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
Published September 6, 2017 · Recall initiated: July 24, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
- Lot
- Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.