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Recall Observatory FDA recall evidence

Device 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.

Z-0696-2021

November 20, 2020

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 86869
Status
Terminated
Classification
Class II
Quantity
4713
Official record key
device-enforcement:Z-0696-2021

Official wording

Reason: Device has the potential for fracture during use.

Code information: All lots

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Device has the potential for fracture during use.