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

Recall Z-0831-2016 — NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, ost

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

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0831-2016
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): 11003331

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

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.

Related