Recall Z-0134-2007 ยท HWC Screw, Fixation, Bone
DePuy Spine, Inc.
Large Halo Crown, DePuy Spine Bremer Halo System Product Number: HT026
| Date | Nov 2, 2006 (initiated Oct 10, 2006) |
| Status | Terminated |
| Reason | Sterility of device is compromised due to loss of package integrity |
| Root cause | Other |
| Action | DePuy Spine notified US consignees by letter via FedEX on 10/10/06 addressed to Materials Management. Outside the US noitifcation made to DePuy Spine and Distributors, recalls will be conducted by the foreign subsidiaries. |
| Quantity | 4843 units |
| Distribution | Nationwide and Australia, New Zealand, Germany, Canada, Czech Republic, Netherlands, Portugal, Sweden, UK, Japan, Indonesia, Italy, Belgium, Hong Kong, Poland, Spain, Switzerland, Taiwan, Turkey, Chile, Egypt, Guatemala, Hungary, Israel, Greece, Thailand, Mexico, Colombia, Venezuela, Slovenia |
| FDA record | Open on fda.gov |