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U.S. Department of Health and Human Services

Class 2 Device Recall Vitality Spinal Fixation System

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 Class 2 Device Recall Vitality Spinal Fixation Systemsee related information
Date Initiated by FirmOctober 16, 2023
Date PostedJanuary 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0639-2024
Recall Event ID 93650
510(K)NumberK150896 
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
ProductVitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Code Information UDI-DI: 00889024002159, Lot: W834061
Recalling Firm/
Manufacturer		 Zimmer Biomet Spine Inc.
10225 Westmoor Dr
Westminster CO 80021-2702
For Additional Information ContactAlexandra Hayden
720-894-9016
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 10/16/23, recall notices were sent to customers asking them to do the following: 1) Locate, quarantine, and return affected screws to the recalling firm. 2) Complete and return the inventory return certificate form via email to Alex.Hayden@ZimVie.com Recall-related questions or concerns can be directed to please email Alex.Hayden@ZimVie.com.
Quantity in Commerce3
DistributionUS Nationwide distribution in the states of MN, NE.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NKB
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