ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate a
FDA device recall Z-0451-05 · posted 2005-01-28 · Terminated
Recall details
- Recalling firm
- Warsaw Orthopedic, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 182
- Distribution
- Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
- Date initiated
- 2005-01-04
- Date posted
- 2005-01-28
- Date terminated
- 2005-06-30
- Location
- Warsaw, IN
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