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
This recall has been terminated (originally issued July 24, 2017).
- Company
- Smith & Nephew Inc
- Recall Initiated
- July 24, 2017
- Terminated
- August 21, 2020
- Recall Number
- Z-3100-2017
- Quantity
- 402 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948
Root Cause
Device Design
Action Taken
Smith & Nephew sent an Urgent Medical Device Recall Notice dated July 24, 2017, to all affected consignees. The firm notified their consignees by email and Fed Ex on 07/24/2017. Consignees have been asked to inspect inventory to locate and quarantine affected product. All consignees were asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew. Customers with questions were instructed to contact FieldActions@smith-nephew.com. For questions regarding this recall call 978-749-1440.