Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Summary
The FDA issued a Class II for Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and by Zimmer Biomet Spine Inc.. 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 d.
Details
Source
Device Recall
External ID
Z-0639-2024
Action Date
2024-01-10
Status
Ongoing
Category
device
Product Description
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Lot/Code Info: UDI-DI: 00889024002159, Lot: W834061
Quantity Affected: 3
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.
Distribution
US Nationwide distribution in the states of MN, NE.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-16
Company
Westminster, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 84 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zimmer Biomet Spine Inc. has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zimmer Biomet Spine Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zimmer Biomet Spine Inc. have FDA actions?
Zimmer Biomet Spine Inc. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0639-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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