Recall Z-0696-2021 ยท HXZ Cutter, Wire
Zimmer Biomet, Inc.
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.
| Date | Nov 20, 2020 |
| Status | Terminated |
| Reason | Device has the potential for fracture during use. |
| Root cause | Under Investigation by firm |
| Action | The firm distributed Urgent Medical Device Recall and Notice of Discontinuation letters to affected customers on November 20, 2020. Customers were informed of the product's potential for fracture during use. Customers were asked to locate and quarantine affected product and to return all affected product to the firm. The firm is discontinuing this product; it will not longer be available. If you have questions regarding this recall, please contact the firm's customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operatin |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.