Z-1023-2009

Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI...

Name: Z-1023-2009 Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2008-10-10
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-10-10 / Terminated / root cause: design

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2008-10-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1023-2009
Status: Terminated
Initiated: 2008-10-10
Posted: 2009-03-10
Terminated: 2010-10-27
Recalling firm: Stryker Corp.
Product: 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.
Product code: KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: Serial numbers 0817003173 through 0825905983.

Product code KIJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)