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

Recall Z-0111-2017 — Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision

U.S. FDA — Device Enforcement · United States · 2016-08-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0111-2017
Date of alert: 2016-08-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Biomet, Inc.
Product category: device
Product type: Devices

Reported risk: Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure. As the augment will not assemble with femoral component due to its shape, it would be easily identified during 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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