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

Recall Z-1803-2014 — EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.

U.S. FDA — Device Enforcement · United States · 2014-04-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1803-2014
Date of alert: 2014-04-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet, Inc.
Product category: device
Product type: Devices

Reported risk: The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

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.

Recall Z-1803-2014 — EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.

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