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

Recall Z-0542-2019 — Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.

U.S. FDA — Device Enforcement · United States · 2018-10-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0542-2019
Date of alert: 2018-10-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Biomet, Inc.
Product category: device
Product type: Devices

Reported risk: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility

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-0542-2019 — Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.

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