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

Recall Z-2150-2020 — Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM

U.S. FDA — Device Enforcement · United States · 2020-04-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2150-2020
Date of alert: 2020-04-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00880304271869

Reported risk: Potential presence of elevated endotoxin levels that exceed the specification limit

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.

Recall Z-2150-2020 — Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM

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