Vitality Polyaxial Screw recall: Labeling Error
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Why was Vitality Polyaxial Screw recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00889024002159, Lot: W834061
- Product
- Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
- Recalling firm
- Zimmer Biomet Spine Inc.
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of MN, NE.
- Recall date
- January 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)