Reported Jan 10, 2024 · Ongoing
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Zimmer Biomet Spine Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet Spine Inc. · 10225 Westmoor Dr · Westminster, CO · 80021-2702
Is this the product you have?
- Vitality Polyaxial Screw, 7.5mmx 50mm
- REF07.02000.118, used with Vitality and Vital Spinal Fixation System
- Lot codes and dates
- UDI-DI00889024002159
- LotW834061
- Amount recalled
- 3
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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