FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6208-000-000S4. The product is an oscillating cutting device used for cutting bone and bone related tissue.
- Recall number
- Z-1029-2009
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6208-000-000S4. The product is an oscillating cutting device used for cutting bone and bone related tissue.
- Status
- Terminated
- Initiated
- 2008-10-10
- Posted
- 2009-03-10
- Terminated
- 2010-10-27
- 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, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
- Lot, serial or model codes
- Serial numbers 0801802893 through 0801802913.
- 510(k) numbers
- ["K943323","K972367"]
- PMA numbers
- not on file
- Product code
- KIJ
- Firm FEI
- 1811755
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28