ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-145.
FDA Recall Z-0451-05 · Posted 2005-01-28
Recalling FirmWarsaw Orthopedic, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2005-01-04
Date Terminated2005-06-30
Product Quantity182
Reason for Recall
The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
Firm 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.
Root Cause
Other
Distribution Pattern
Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.