Stryker MIS Bur, 3.0mm Neuro Diamond Course, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-230.
FDA device recall Z-0599-2010 · posted 2010-01-11 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
- Action taken
- Consignees were sent a letter dated 7/10/09 instructing them to locate and return product on hand for replacement. Surgeons who use the product were notified via a separate, untitled letter, dated July 13, 2009. A speed warning will be added to the product labels. Questions are directed to the firm at: 1-800-800-4236 ext. 3808.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HBE
- Quantity affected
- 5438 of all products
- Distribution
- Nationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan.
- Date initiated
- 2009-07-06
- Date posted
- 2010-01-11
- Date terminated
- 2010-10-25
- Location
- Kalamazoo, 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) (K040300) | Stryker Instruments | 2004-03-03 |
| STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (K032303) | Stryker Instruments | 2004-01-16 |