Recall Z-1025-2009 ยท KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Mar 10, 2009 (initiated Oct 10, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 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, Sin |
| FDA record | Open on fda.gov |