Z-0696-2021 Class II Terminated
FDA device recall Z-0696-2021 was initiated by Zimmer Biomet, Inc. on November 20, 2020 and is designated Class II. Reason for recall: Device has the potential for fracture during use. The recall status is terminated (terminated May 26, 2022). Affected quantity: 4713.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 20, 2020
- Termination Date
- May 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4713
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.
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.
Code Information
All lots