FDA Medical Device Recalls (openFDA)
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 786-140.
- Recall number
- Z-0449-05
- 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 786-140.
- Status
- Terminated
- Initiated
- 2005-01-04
- Posted
- 2005-01-28
- Terminated
- 2005-06-30
- 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
- 121
- Distribution
- Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
- Lot, serial or model codes
- Lots 634570 and 802070.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 1824199
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28