Recall Z-0639-2024— Zimmer Biomet Spine Inc.
Class II · Ongoing
Class II FDA medical device recall by Zimmer Biomet Spine Inc., initiated 2023-10-16. It names one FDA 510(k) clearance: K150896. Product: Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System. Reason: 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..
- Recalling firm
- Zimmer Biomet Spine Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-16
- Firm location
- Westminster, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.