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

Recall Z-0457-2021 — Osteosynthesis Compression Staple EasyClip

U.S. FDA — Device Enforcement · Switzerland · 2020-09-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0457-2021
Date of alert
2020-09-25
Country / jurisdiction
Switzerland
Risk level
Class II
Risk type
recall
Brand
Stryker GmbH
Product category
device
Product type
Devices
Reported risk: The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.
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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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.