Recall Z-0570-2021 ยท NKB Thoracolumbosacral Pedicle Screw System
Zimmer Biomet, Inc.
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
| Date | Nov 17, 2020 |
| Status | Terminated |
| Reason | Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system. |
| Root cause | Use error |
| Action | On November 17, 2020, the firm distributed Urgent Medical Device Correction letters to customers. Customers were notified that changes were made to the contraindications section indicating the following: "Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system." The updated instruction for use is available electronically at labeling.zimmerbiomet.com, and the updated surgical technique is available electronically at zimmerbiomet.com. Customer |
| Quantity | 57,715 units |
| Distribution | Domestic distribution nationwide. As direct stimulation devices are only available in the US, this contraindication does not apply to international customers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140123 | POLARIS SPINAL SYSTEM -TRANSLATION SCREW Ebi, LLC, Apr 24, 2014 |