Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.
FDA device recall Z-0263-2010 · posted 2009-11-16 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.
- Action taken
- Consignees were notified by letter dated 10/5/09 and requested to return the devices to Stryker. The international account was notified by email.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- DZI
- Quantity affected
- 93
- Distribution
- USA (California, Georgia, Louisiana, Ohio, Wisconsin) and Brazil.
- Date initiated
- 2009-10-05
- Date posted
- 2009-11-16
- Date terminated
- 2009-11-30
- 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) SYSTEM (K040369) | Stryker Instruments | 2004-04-01 |