Vitality Polyaxial Screw — Class II medical device recall Z-0639-2024
Ongoing recall by Zimmer Biomet Spine Inc., reported 2024-01-10, distributed nationwide. Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves we
| Recall number | Z-0639-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet Spine Inc., Westminster, CO, United States |
| Recall initiated | 2023-10-16 |
| Classified | 2024-01-04 |
| Reported by FDA | 2024-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00889024002159 |
| Lot numbers | W834061 |
| Model numbers | 07.02000.118 |
Product
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0639-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.