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U.S. FDA — Device Enforcement · United States · 2017-02-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1861-2017
Date of alert: 2017-02-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Biomet, Inc.
Product category: device
Product type: Devices

Reported risk: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

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.

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