FDA-Device2020-12-30Class II

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.

Zimmer Biomet, Inc.
Hazard

Device has the potential for fracture during use.

Sold states
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.
Affected count
4713
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0696-2021

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