FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker Navigation Pin for use with the Stryker Navigation System, 3 mm x 150 mm, Stryker, Kalamazoo, MI; Part 6007-003-150. Stryker Navigation Pin for use with the Stryker Navigation System is used for trauma and orthopedic applications, e.g. hip and knee modules.
- Recall number
- Z-2289-2008
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker Navigation Pin for use with the Stryker Navigation System, 3 mm x 150 mm, Stryker, Kalamazoo, MI; Part 6007-003-150. Stryker Navigation Pin for use with the Stryker Navigation System is used for trauma and orthopedic applications, e.g. hip and knee modules.
- Status
- Terminated
- Initiated
- 2008-06-05
- Posted
- 2008-09-16
- Terminated
- 2009-12-01
- Reason
- Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Root cause
- Labeling False and Misleading
- Action
- Consignees were notified via letter dated 6/5/08 providing them with additional warnings and instructions for use for these products. Contact Stryker Customer Service at 1-800-800-4236, ext. 3808.
- Quantity
- 28,861 boxes of all products.
- Distribution
- Nationwide, Austria, Australia, Brazil, Canada, China, Dubai, England, France, Germany, Hong Kong, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Singapore, South Africa, South Korea, Sweden, Switzerland and Taiwan.
- Lot, serial or model codes
- All units distributed prior to 6/5/08.
- 510(k) numbers
- ["K022365","K022579"]
- PMA numbers
- not on file
- Product code
- HAW
- 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