—#74687

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.

FDA product code: KIJ — Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K943323, K972367
Affected lot / code info: Serial numbers 0614504853 through 0825902483.

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002

Distribution

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.

Timeline

Recall initiated: 2008-10-10
Posted by FDA: 2009-03-10
Terminated: 2010-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74687. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.