Recall Z-0639-2024 ยท NKB Thoracolumbosacral Pedicle Screw System
Zimmer Biomet Spine Inc.
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
| Date | Jan 4, 2024 (initiated Oct 16, 2023) |
| Status | Open, Classified |
| Reason | Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/16/23, recall notices were sent to customers asking them to do the following: 1) Locate, quarantine, and return affected screws to the recalling firm. 2) Complete and return the inventory return certificate form via email to Alex.Hayden@ZimVie.com Recall-related questions or concerns can be directed to please email Alex.Hayden@ZimVie.com. |
| Quantity | 3 |
| Distribution | US Nationwide distribution in the states of MN, NE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150896 | Vitality Spinal Fixation System Zimmer Spine, Inc., Aug 31, 2015 |