Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Vitality Spinal Fixation System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Vitality Spinal Fixation System see related information
Date Initiated by Firm October 16, 2023
Date Posted January 04, 2024
Recall Status1 Open3, Classified
Recall Number Z-0639-2024
Recall Event ID 93650
510(K)Number K150896  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product Vitality 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 Contact Alexandra 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
Action On 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 Commerce 3
Distribution US Nationwide distribution in the states of MN, NE.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = NKB and Original Applicant = ZIMMER SPINE, INC.
-
-