Recall Z-0447-05 ยท HWC Screw, Fixation, Bone
Warsaw Orthopedic, Inc.
ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-125.
| Date | Jan 28, 2005 (initiated Jan 4, 2005) |
| Status | Terminated |
| Reason | The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit. |
| Root cause | Other |
| Action | Consignees were notified, via a recall letter dated 12/27/04 and issued on 1/4/05, to return the product. Competent Authorities were notified via letter dated 1/12/05. |
| Quantity | 142 |
| Distribution | Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.