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

Recall Z-0603-2020 — Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can

U.S. FDA — Device Enforcement · United States · 2019-01-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0603-2020
Date of alert: 2019-01-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Miami Device Solutions, LLC.
Product category: device
Product type: Devices

Reported risk: Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.

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.

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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