Date Initiated by Firm |
July 08, 2013 |
Date Posted |
August 27, 2013 |
Recall Status1 |
Terminated 3 on March 31, 2015 |
Recall Number |
Z-2099-2013 |
Recall Event ID |
65891 |
510(K)Number |
K000080
|
Product Classification |
Screw, fixation, bone - Product Code HWC
|
Product |
Stryker 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 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact |
Ms. 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 |
Action |
Stryker 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 Commerce |
23 units |
Distribution |
USA Nationwide Distribution in the states of: FL. OH, TX, & VA |
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 = HWC and Original Applicant = HOWMEDICA OSTEONICS CORP.
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