Recall Z-0263-2010
Stryker Instruments Div. of Stryker Corporation · initiated October 5, 2009
Product
Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.
Codes / lots: Lots 08311017 and 08336027.
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.
FDA-determined cause: Vendor change control
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.
Details
- Recall number
- Z-0263-2010
- Initiated
- October 5, 2009
- Posted by FDA
- November 16, 2009
- Terminated
- November 30, 2009
- Product code
- DZI – Drill, Bone, Powered
- Quantity
- 93
- Distribution
- USA (California, Georgia, Louisiana, Ohio, Wisconsin) and Brazil.
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation, Kalamazoo, MI