Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
FDA device recall Z-0639-2024 · posted 2024-01-04 · Open, Classified
Recall details
- Recalling firm
- Zimmer Biomet Spine Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- NKB
- Quantity affected
- 3
- Distribution
- US Nationwide distribution in the states of MN, NE.
- Date initiated
- 2023-10-16
- Date posted
- 2024-01-04
- Location
- Westminster, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Vitality Spinal Fixation System (K150896) | Zimmer Spine, Inc. | 2015-08-31 |