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 786-123. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-123.
Brand
Warsaw Orthopedic, Inc.
Lot Codes / Batch Numbers
Lots 796010 and 634540.
Products Sold
Lots 796010 and 634540.
Warsaw Orthopedic, Inc. is recalling ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screw due to The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026