Stryker Precision Oscillating Tip Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6209. The
FDA device recall Z-1030-2009 · posted 2009-03-10 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KIJ
- Quantity affected
- 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, Malaysi
- Date initiated
- 2008-10-10
- Date posted
- 2009-03-10
- Date terminated
- 2010-10-27
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT (K972367) | Stryker Instruments | 1997-09-04 |
| STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES (K943323) | Stryker Corp. | 1994-11-28 |