• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stryker AVS Navigator

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


New Search Back to Search Results
 Class 2 Recall
Stryker AVS Navigator
see related information
Date Posted July 19, 2012
Recall Status1 Terminated on July 29, 2013
Recall Number Z-2033-2012
Recall Event ID 61723
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.
Code Information Class I; 510(k) Exempt Description: AVS¿ Navigator Trials. Size 6mm -15mm. Catalog Number: 48392206,48392207,48392208,48392209,48392210, 48392211,48392212,48392213,48392214,48392215. Lot Code: 104864,104866, 104867, 104868, 104869, 104870, 10E331, 104871, 104872, 104873, 104874, 104875.
Recalling Firm/
Manufacturer
Stryker Spine
2 Pearl Ct
Allendale, New Jersey 07401-1611
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Michelle Barry
201-760-8287
Manufacturer Reason
for Recall
Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head.
FDA Determined
Cause 2
DESIGN: Device Design
Action Stryker sent an "URGENT PRODUCT RECALL" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was included for customers to complete and return via fax to Regulatory Compliance at 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this recall.
Quantity in Commerce 273 units
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-