FDA recall Z-0696-2021

Product

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.

Reason for recall

Device has the potential for fracture during use.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2020-11-20

Report date

2020-12-30

Termination date

2022-05-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

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