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

Recall Z-1011-2022 — Smart Toe II Intramedullary Arthrodesis Implant

U.S. FDA — Device Enforcement · Switzerland · 2022-03-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1011-2022
Date of alert
2022-03-28
Country / jurisdiction
Switzerland
Risk level
Class II
Risk type
recall
Brand
Stryker GmbH
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613252263470
Reported risk: The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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