FDA Device recall Z-2912-2018
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, 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 PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, 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-2912-2018 |
| 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 PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, 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 | 1000201620, 1000203741, 1000215161, 1000221838, 1000224226, 1000230171, 1000232403, 1000233774, 1000235432, 1000236133…1000201620, 1000203741, 1000215161, 1000221838, 1000224226, 1000230171, 1000232403, 1000233774, 1000235432, 1000236133, 1000238416, 1000245179, 1000251379, 1000254404, 1000255711, 1000257449, 1000258651, 1000258652, 1000259409, 1000260283, 1000260284, 1000260285, 1000261025, 1000261026, 1000261689, 1000261690, 1000261691, 1000263498, 1000263499, 1000263500, 1000263501, 1000263502, 1000264407, 1000264408, 1000265423, 1000265424, 1000266165, 1000266166, 1000266167, 1000267009, 1000267010, 1000267748, 1000267749, 1000267750, 1000268573, 1000268574, 1000269518, 1000269519, 1000270162, 1000270163, 1000270837, 1000270838, 1000285715, 1000287395, 1000289257, 1000201620, 1000288210, 1000290246, 1000291275, 1000292116, 1000294081 |
|---|
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-2912-2018%22
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