Recall Z-1009-2008 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker Instruments Div. of Stryker Corporation
Stryker 10.0 mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-100.
| Date | Apr 22, 2008 (initiated Jan 10, 2008) |
| Status | Terminated |
| Reason | Lack of assurance of sterility. |
| Root cause | Package design/selection |
| Action | 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. |
| Quantity | 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 Africa, Spain, Sweden, Switzerland and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032303 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM Stryker Instruments, Jan 16, 2004 |