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U.S. Department of Health and Human Services

Class 2 Device Recall AXSOS PLUS LOCKING PLATE SYSTEM

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 Class 2 Device Recall AXSOS PLUS LOCKING PLATE SYSTEMsee related information
Date Initiated by FirmNovember 24, 2008
Date PostedApril 13, 2009
Recall Status1 Terminated 3 on April 06, 2010
Recall NumberZ-1063-2009
Recall Event ID 50850
510(K)NumberK061012 
Product Classification AxSOS Torque Limiting Screwdriver - Product Code HRS
ProductAxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set. REF 702749. This product is non sterile. Distributed in the USA by Howmedica Osteonics Corp, Mahwah, NJ. The torque limiter is used for final tightening locking screws to the plate in order to avoid over tightening of the locking screws.
Code Information All lot codes.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information ContactKaren Ariemma, RAC
201-831-5000
Manufacturer Reason
for Recall		Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.
FDA Determined
Cause 2		Other
Action"Urgent Product Recall" letters were sent to Stryker Orthopaedics Branches/Agencies, Chief of Orthopaedics, Hospital Risk Management and Surgeons on November 24, 2008 via Federal Express. The letters described the issue and provided the following instructions: 1. Examine your inventory and determine if you have any of the affected product, 2. Remove and quarantine affected product from your inventory, 3. Complete the attached Product Recall Acknowledgement Form (and fax to Stryker Orthopaedics at 201-831-6069), and 4. Return the affected product to your Stryker Orthopaedics Sales representative. Direct questions to your Stryker Orthopaedics Sales Representative or call Stryker Orthopaedics at 201-831-5000.
Quantity in Commerce415 units
DistributionNationwide Distribution.
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 = HRS
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