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U.S. Department of Health and Human Services

Class 2 Device Recall Asnis III Csnnulated Screw System

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 Class 2 Device Recall Asnis III Csnnulated Screw Systemsee related information
Date Initiated by FirmJuly 08, 2013
Date PostedAugust 27, 2013
Recall Status1 Terminated 3 on March 31, 2015
Recall NumberZ-2099-2013
Recall Event ID 65891
510(K)NumberK000080 
Product Classification Screw, fixation, bone - Product Code HWC
ProductStryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
Code Information Catalog # 604640, Lot Code R11428 21 units  Catalog # 604642S, Lot Code R09071 1 unit  
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactMs. Christie Samsa
201-831-6365
Manufacturer Reason
for Recall		Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.
FDA Determined
Cause 2		Process control
ActionStryker sent an Urgent Medical Device Removal letter dated July 8, 2013 via Fed Ex to all affected customers. The letter identified the affected product, product issues, potential hazards, risk mitigation and actions to be taken. Customers were instructed to return all affected products available to Stryer Osteosynthesis or contact Stryer customer service and complete and sign the enclosed Business Reply Form and fax a copy to: 1-865-251-3635. Questions can be directed to Stryker at 201-972-2100.
Quantity in Commerce23 units
DistributionUSA Nationwide Distribution in the states of: FL. OH, TX, & VA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HWC
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