Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
This recall is currently active, issued January 4, 2024. It was issued by Zimmer Biomet Spine Inc..
- Company
- Zimmer Biomet Spine Inc.
- Recall Initiated
- October 16, 2023
- Posted
- January 4, 2024
- Recall Number
- Z-0639-2024
- Quantity
- 3
- Firm Location
- Westminster, CO
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of MN, NE.
Lot / Code Info
UDI-DI: 00889024002159, Lot: W834061
Root Cause
Nonconforming Material/Component
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.