Smith & Nephew, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3100-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 24, 2017

Date Posted: September 6, 2017

Recall Number: Z-3100-2017

Event ID: 77827

Reason for Recall:

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

Status: Terminated

Product Quantity: 402 units

Code Information:

Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated