FDA Device recall Z-2910-2018
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
- FDA Device
- Class II
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class II recall of AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium by Stryker Leibinger And Kg, citing after a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2910-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-22 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Leibinger And Kg |
| Distribution | AZ, FL, NH, OH |
Product
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
Reason
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Identifiers
| code_info | 1000201514, 1000203740, 1000216825, 1000220166, 1000233195, 1000237514, 1000238415, 1000245178, 1000252563, 1000254189…1000201514, 1000203740, 1000216825, 1000220166, 1000233195, 1000237514, 1000238415, 1000245178, 1000252563, 1000254189, 1000254403, 1000255709, 1000256557, 1000257448, 1000258647, 1000258648, 1000258649, 1000259406, 1000259407, 1000260281, 1000260282, 1000261023, 1000261024, 1000261687, 1000261688, 1000262515, 1000262516, 1000262517, 1000263497, 1000264403, 1000264404, 1000264405, 1000265422, 1000268571, 1000268572, 1000201514, 1000287394, 1000292115, 1000293285, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2910-2018%22
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