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

Recall Z-0399-2019 — StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent,

U.S. FDA — Device Enforcement · United States · 2018-09-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0399-2019
Date of alert: 2018-09-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Biomet, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00880304447165

Reported risk: There is a potential for comingling of the 43MM and 51 MM molds

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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