Spinal fixation screws recalled due to incorrect size laser marking
Zimmer Biomet Spine Inc. is recalling Vitality Polyaxial Screws (7.5mm x 50mm) due to incorrect laser marking showing 7.5 x 40. Incorrect screw size could cause perforation and vascular damage during spinal surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a spinal fixation device where incorrect laser marking could lead to implantation of wrong-sized screws, potentially causing vascular injury or perforation. No injuries have been reported in the source text, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet Spine Inc. is recalling Vitality Polyaxial Screws, 7.5mm x 50mm (REF: 07.02000.118), used with Vitality and Vital Spinal Fixation Systems. Three units from lot W834061 (UDI-DI: 00889024002159) were distributed to healthcare facilities.
The screws are packaged with correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40 instead of 7.5 x 50. This creates a discrepancy between the package label and the actual marking on the device.
Use of incorrect size screws could lead to screw perforation and indention of vascular or other structures, creating a risk of serious surgical complications. Healthcare providers and facilities that received this product should verify they are using the correct screw size by relying on the package labeling and not the laser marking.
The recalled product
- Product
- Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
- Manufacturer
- Zimmer Biomet Spine Inc.
- Category
- Medical Device — Spinal Fixation
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00889024002159
- Lot: W834061
Distribution
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