FDA Medical Device Recalls (openFDA)
Zimmer Biomet Spine Inc.: Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
- Recall number
- Z-0639-2024
- Recalling firm
- Zimmer Biomet Spine Inc.
- Product
- Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
- Status
- Open, Classified
- Initiated
- 2023-10-16
- Posted
- 2024-01-04
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI-DI: 00889024002159, Lot: W834061
- 510(k) numbers
- ["K150896"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3012447612
- Firm city
- Westminster
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28