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Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usag...

FDA Recall #Z-0696-2021 — Class II — November 20, 2020

Recall #Z-0696-2021 Date: November 20, 2020 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Zimmer Biomet, Inc. — Warsaw, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

4713

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.

Code Information

All lots

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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