Z-0447-05

ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver...

Name: Z-0447-05 ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver...
Creator: Warsaw Orthopedic, Inc.
Published: 2005-01-04
License: https://open.fda.gov/license/

Warsaw Orthopedic, Inc. / initiated 2005-01-04 / Terminated

FDA source

Warsaw Orthopedic, Inc. began a recall of 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 on 2005-01-04. The reason FDA records is "The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0447-05
Status: Terminated
Initiated: 2005-01-04
Posted: 2005-01-28
Terminated: 2005-06-30
Recalling firm: Warsaw Orthopedic, Inc.
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 786-125.
Product code: HWC Screw, Fixation, Bone
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.
FDA 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 in commerce: 142
Distribution: Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
Product codes and lots: Lots 634550, 796050 and 796040.

Product code HWC

The FDA recall record names no cleared device, and no clearance has been matched to it.

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)