FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker Instruments 8.omm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-180.
- Recall number
- Z-1014-2008
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker Instruments 8.omm XX Coarse Round Diamond Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-13-180.
- Status
- Terminated
- Initiated
- 2008-01-10
- Posted
- 2008-04-22
- Terminated
- 2009-12-01
- Reason
- Lack of assurance of sterility.
- Root cause
- Package design/selection
- Action
- Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
- Quantity
- 10,588 of all products
- Distribution
- Worldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K032303"]
- PMA numbers
- not on file
- Product code
- HBE
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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