Recall Z-1008-2007 ยท HBB Motor, Drill, Pneumatic
The Anspach Effort, Inc.
Anspach Single Use, Sterile Bone Cutting Burrs
| Date | Jul 11, 2007 (initiated May 18, 2007) |
| Status | Terminated |
| Reason | The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product. |
| Root cause | Nonconforming Material/Component |
| Action | The firm issued a recall letter on May 18, 2007, to its consignee, advising them of the recall. Consignees were asked to screen their inventory for the recalled devices and complete an accompanying product replacement form. The firm will replace all returned product within 30 days. |
| Quantity | 1,962,123 |
| Distribution | World wide-Distributed throughout the United States and to Puerto Rico, Canada, Mexico, Japan, Lithuania, Cyprus, Austrailia, England, Sweden, Bahamas, Korea, Germany, Switzerland, Malaysia, Iceland, Portugal, Singapore, Poland, Hungary, Thailand, Austria, Israel, Belgium, Egypt, South Africa, Nethe |
| FDA record | Open on fda.gov |