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

Recall Z-2297-2016 — SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or nonin

U.S. FDA — Device Enforcement · United States · 2016-07-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2297-2016
Date of alert: 2016-07-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smith & Nephew, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 71332525

Reported risk: The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.

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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