Spinal Rod Cutter recalled over sterility concerns

Recall date

November 20, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Zimmer Biomet, Inc. recalls Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of…

Recall number

Z-0696-2021

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Domestic distribution nationwide. Foreign distribution to Australia, China, Hong Kong, India, Japan, Korea, New Zealand, Taiwan, Singapore, Thailand, Canada, Netherlands, Argentina, Brazil, Mexico, Venezuela, Panama, and Chile.

Why it was recalled

Device has the potential for fracture during use.

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

What was recalled

Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.