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

Recall Z-0843-2016 — CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen

U.S. FDA — Device Enforcement · United States · 2016-01-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0843-2016
Date of alert
2016-01-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
61790499
Reported risk: LDPE bag containing the implant adheres to the highly polished implant surface.
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.