Z-0639-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2024
- Initiation Date
- October 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of MN, NE.
Code Information
UDI-DI: 00889024002159, Lot: W834061