Stryker 6.0 mm Barrel Bur, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-17-60.
FDA device recall Z-1015-2008 · posted 2008-04-22 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- Lack of assurance of sterility.
- Action taken
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- HBE
- Quantity affected
- 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
- Date initiated
- 2008-01-10
- Date posted
- 2008-04-22
- Date terminated
- 2009-12-01
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (K032303) | Stryker Instruments | 2004-01-16 |