Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 t

U.S. FDA — Device Enforcement · United States · 2017-07-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3100-2017
Date of alert: 2017-07-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smith & Nephew, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 76102260

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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