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

Recall Z-1649-2022 — Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half

U.S. FDA — Device Enforcement · United States · 2020-12-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1649-2022
Date of alert
2020-12-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
New Standard Device Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
854641008198
Reported risk: Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
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.