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

Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus. — recall Z-2785-2020

U.S. FDA — Device Enforcement · United States · 2020-07-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2785-2020
Date of alert
2020-07-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Flower Orthopedics Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
1909660034
Reported risk: The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.