Recall Z-0596-2010 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker Instruments Div. of Stryker Corporation
Stryker MIS Bur, 2.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-125.
| Date | Jan 11, 2010 (initiated Jul 6, 2009) |
| Status | Terminated |
| Reason | The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 5438 of all products |
| Distribution | Nationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan. |
| FDA record | Open on fda.gov |