Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
FDA Recall Z-0639-2024 · Posted 2024-01-04
Recalling FirmZimmer Biomet Spine Inc.
Recall StatusOpen, Classified
Product CodeNKB
Date Initiated2023-10-16
Product Quantity3
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.
Firm 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 [email protected]
Recall-related questions or concerns can be directed to please email [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of MN, NE.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.