Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203-000-000S1. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.
FDA Recall Z-1023-2009 · Posted 2009-03-10
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeKIJ
Date Initiated2008-10-10
Date Terminated2010-10-27
Product Quantity25,312 of all units
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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