—#157987

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

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K130728
Affected lot / code info: Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

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

Timeline

Recall initiated: 2017-07-24
Terminated: 2020-08-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157987. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.