FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker VertePort, 10 G Access Cannula w/Long Stylet System, REF 306-400, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
- Recall number
- Z-1192-2008
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker VertePort, 10 G Access Cannula w/Long Stylet System, REF 306-400, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
- Status
- Terminated
- Initiated
- 2008-02-13
- Posted
- 2008-03-11
- Terminated
- 2008-12-30
- Reason
- Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)
- Root cause
- Labeling Change Control
- Action
- Consignees were notified via Medical Device Recall Notification letter dated 2/13/08 to read the enclosed instructions for use, remove all old instructions for use at the consignee location and replace them with the new instructions for use, and to discard the old instructions for use.
- Quantity
- 953 boxes Recalls Z-1192-1195-2008
- Distribution
- Nationwide.
- Lot, serial or model codes
- All Lots- BCWD and BENC
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JDZ
- 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