Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Recall
- Recall Number
- Z-0639-2024
- Event Number
- 93650
- Firm
- Zimmer Biomet Spine Inc.
- FEI Number
- 3012447612
- Product Code
- NKB
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 16, 2023
- Posted
- January 4, 2024
- Address
- 10225 Westmoor Dr, Westminster, CO, 80021-2702
Description
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
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.
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].
US Nationwide distribution in the states of MN, NE.
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