Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00

Recall date
March 26, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1471-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad

Why it was recalled

Potential failure of sterile packaging seal.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00

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