FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker Instruments Navigation System II- CART, Stryker Navigation, Kalamazoo, MI; Stryker REF 7700-100-000. Intended to be used as a component of the Navigation System II.
- Recall number
- Z-0122-2010
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker Instruments Navigation System II- CART, Stryker Navigation, Kalamazoo, MI; Stryker REF 7700-100-000. Intended to be used as a component of the Navigation System II.
- Status
- Terminated
- Initiated
- 2009-10-26
- Posted
- 2009-11-20
- Terminated
- 2009-12-31
- Reason
- Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very slowly.
- Root cause
- Software design
- Action
- The firm issued a press release on 11/4/09. Consignees were notified by an Urgent: Medical Device Recall Notification letter dated 10/23/09, which advised of the affected products, the reason for the recall, the recall plan, and the actions to be taken. Customers were to immediately review this notification and distribute to all departments affected. Also, customers were to immediately quarantine any affected product and label as recalled product; complete and sign the enclosed Business Reply Form and fax a copy to 866-521-2762. Upon receipt of the form, a Stryker Navigation Field Service Rep would contact them to schedule the repair of their equipment. All U.S. units were corrected by 10/30/09.
- Quantity
- 21
- Distribution
- Worldwide Distribution -- USA, including states of Florida, Kansas, Kentucky, Massachusetts, Michigan, New Jersey, Pennsylvania, South Carolina, Texas, and Washington and countries of Australia, China, Germany, Japan, Korea, Switzerland, and the United Kingdom.
- Lot, serial or model codes
- Serial number range 100715 through 100735.
- 510(k) numbers
- ["K993239"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1811755
- Firm city
- Kalamazoo
- 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