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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker System 6 Rotary Handpiece

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  Class 2 Device Recall Stryker System 6 Rotary Handpiece see related information
Date Initiated by Firm October 10, 2008
Date Posted March 10, 2009
Recall Status1 Terminated 3 on October 27, 2010
Recall Number Z-1025-2009
Recall Event ID 50084
510(K)Number K972367  K943323  
Product Classification Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment - Product Code KIJ
Product Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6205-000-000S1.

The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.
Code Information Serial numbers 0807117993 through 0811212433.
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002
For Additional Information Contact
888-311-4521
Manufacturer Reason
for Recall		 The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
FDA Determined
Cause 2		 Component design/selection
Action Consignees were notified of the problem via letter dated October 10, 2008, provided interim instructions to reduce the risk, and informed that Stryker instruments will replace the trigger on all handpieces. Consignees were also instructed on the following: 1) Review the letter and distribute to all affected departments, 2) Complete and sign the enclosed Business Reply Form and fax to 336-499-8603 and 3) Call Stryker Instruments Service Department at 888-308-1983 to schedule service for the handpieces.
Quantity in Commerce 25,312 of all units
Distribution Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
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 = KIJ and Original Applicant = STRYKER CORP.
510(K)s with Product Code = KIJ and Original Applicant = STRYKER INSTRUMENTS
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