Class 2 Device Recall Stryker System 6 Rotary Handpiece

• Date Initiated by Firm: October 10, 2008
• Date Posted: March 10, 2009
• Recall Status: Terminated on October 27, 2010
• Recall Number: Z-1022-2009
• Recall Event ID: 50084
• 510(K)Number: K943323 K972367
• Product Classification: Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment - Product Code KIJ
• Product: Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203. 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 0614504853 through 0825902483.
• 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: 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; 510(K)s with Product Code = KIJ