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

Recall Z-2132-2020 — JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable spikes (spike rail)

U.S. FDA — Device Enforcement · United States · 2020-01-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2132-2020
Date of alert: 2020-01-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smith & Nephew, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 74035821

Reported risk: The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

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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