Z-3100-2017 Class II Terminated
FDA device recall Z-3100-2017 was initiated by Smith & Nephew, Inc. on July 24, 2017 and is designated Class II. Reason for recall: The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures. The recall status is terminated (terminated August 21, 2020). Affected quantity: 402 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2017
- Initiation Date
- July 24, 2017
- Termination Date
- August 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 402 units
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.
Distribution Pattern
Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
Code Information
Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948