Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The r…

Recall date
April 3, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1522-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
The product was distributed to the following states: CT, FL, GA, IN, MA, MI, NY, and TX. The product was distributed to the following countries: Malaysia and Netherlands.

Why it was recalled

There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.

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

What was recalled

Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.

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