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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Mantis Rod Inserter Inner Shaft

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  Class 2 Device Recall Stryker Mantis Rod Inserter Inner Shaft see related information
Date Initiated by Firm April 30, 2009
Date Posted July 07, 2009
Recall Status1 Terminated 3 on January 23, 2013
Recall Number Z-1612-2009
Recall Event ID 52090
510(K)Number K061813  
Product Classification Orthosis, spondyloisthesis spinal fixation - Product Code MNH
Product Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS, Cestas France. Distributed by Stryker Spine, Allendale, NJ 07401-1677.

The MANTIS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disk disease, spodylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.
Code Information Catalog Number: 48284051, all lots.   Mantis Rod inserter Shafts supplied separately, Catalog Number: 48284051.
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Ms. Michelle Barry
201-760-8287
Manufacturer Reason
for Recall		 The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall into the patient.
FDA Determined
Cause 2		 Device Design
Action Stryker Spine issued an "Urgent Product Recall" notification dated April 29, 2009 via Federal Express to all Consignees. Users were instructed to quarantine all affected product and fax a copy of the Product Accountability Form to 201-760-8406. A Stryker sales representative will retrieve the quarantined product. For further information, contact Stryker Spine at 201-760-8206.
Quantity in Commerce 387 in US
Distribution Nationwide Distribution.
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 = MNH and Original Applicant = STRYKER SPINE
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