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U.S. Department of Health and Human Services

Class 2 Device Recall ST360 Distal Thread Reduction Guide Pins

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  Class 2 Device Recall ST360 Distal Thread Reduction Guide Pins see related information
Date Initiated by Firm October 05, 2006
Date Posted November 16, 2006
Recall Status1 Terminated 3 on October 29, 2007
Recall Number Z-0190-2007
Recall Event ID 36549
510(K)Number K022374  K041925  
Product Classification spinal reduction guide - Product Code KWP
Product Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Guide Pin is a reusable instrument that is part of a set of instruments used to perform reduction surgeries with the ST360 Spinal Fixation System. The ST360 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, fixed and adjustable transverse connectors.
Code Information Part Number 07.00684.001, Lot numbers: P031530, P031650, P040389, P040111, P051160, P051161
Recalling Firm/
Manufacturer		 Zimmer Spine, Inc.
7375 Bush Lake Rd
Minneapolis MN 55439-2027
Manufacturer Reason
for Recall		 Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing.
FDA Determined
Cause 2		 Other
Action Distributors were notified via email with an Urgent Product Recall letter beginning 10/12/2006. Distributors are to return their own inventory and any hospital consignment inventory by October 20, 2006. A Certification Form is also to be faxed back to Zimmer Spine.
Quantity in Commerce 159
Distribution Nationwide and Japan
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = SULZER SPINE-TECH
510(K)s with Product Code = KWP and Original Applicant = ZIMMER SPINE, INC.
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