| Class 2 Device Recall ST360 Distal Thread Reduction Guide Pins | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KWP 510(K)s with Product Code = KWP
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