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.
Reported: December 30, 2020 Initiated: November 20, 2020 #Z-0696-2021
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product 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.. Recalled by Zimmer Biomet, Inc.. Units affected: 4713.
Why was this product recalled? ▼
Device has the potential for fracture during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0696-2021.
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