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U.S. Department of Health and Human Services

Class 2 Device Recall T2 Ankle Arthrodesis Nail

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  Class 2 Device Recall T2 Ankle Arthrodesis Nail see related information
Date Initiated by Firm December 29, 2009
Date Posted February 24, 2010
Recall Status1 Terminated 3 on August 06, 2012
Recall Number Z-0846-2010
Recall Event ID 54249
510(K)Number K051590  
Product Classification Intramedullary Fixation Rod and Accessories - Product Code HSB
Product Stryker T2 Ankle Arthrodesis Nail, right; 012 x 300 mm; Catalog number: 18191230S;
Sterile, TI Alloy;
Stryker Trauma GmbH, Germany;
Distributed in the US by Howmedica Osteonics Corp, Mahwah, NJ.

Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
Code Information lot codes: K108843, K152964, K171685, K180561, K194187, K227390, K253168, K733141, K776745, K785626, K785652, K802766, K831465, K837694, K868868, and  K999298. 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall		 Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
FDA Determined
Cause 2		 Packaging
Action Urgent Product Recall notification letters were sent to branches on 12/29, 2009, with a corrected version that included a list of catalog numbers and code numbers on January 11, 2009. Letters were also sent by Fed Ex on January 11, 2009 to Hospital Risk Management, Chief of Orthopaedics and surgeons who may have used the device. The letters identified the affected product, described the issue, and the hazards involved. The letter also asked customers to examine their inventory and hospital locations to identify the affected product. They are to retrieve all affected product and return it to their branch or agency warehouse for reconciliation. Customers are to reconcile all products utilizing the Product Recall Accountability Form. Questions should be directed to 201-972-2100.
Quantity in Commerce 702 total, all sizes.
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 = HSB and Original Applicant = HOWMEDICA OSTEONICS CORP.
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