Recall Z-0639-2024
Zimmer Biomet Spine Inc. · initiated October 16, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Codes / lots: UDI-DI: 00889024002159, Lot: W834061
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.
FDA-determined 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.
Details
- Recall number
- Z-0639-2024
- Initiated
- October 16, 2023
- Posted by FDA
- January 4, 2024
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of MN, NE.
- Recalling firm
- Zimmer Biomet Spine Inc., Westminster, CO