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

Recall Z-1115-2017 — Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS

U.S. FDA — Device Enforcement · United States · 2017-01-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1115-2017
Date of alert: 2017-01-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Biomet, Inc.
Product category: device
Product type: Devices

Reported risk: packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.

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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