FDA Device recall Z-2900-2018
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, 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 QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, 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-2900-2018 |
| 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
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, 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 | 1000096159, 1000096935, 1000096936, 1000097334, 1000097915, 1000101820, 1000109424, 1000115216, 1000119029, 1000125079…1000096159, 1000096935, 1000096936, 1000097334, 1000097915, 1000101820, 1000109424, 1000115216, 1000119029, 1000125079, 1000125080, 1000130030, 1000136426, 1000141584, 1000147073, 1000151497, 1000156030, 1000157137, 1000162227, 1000163908, 1000167016, 1000169751, 1000176390, 1000178196, 1000181747, 1000184371, 1000186595, 1000187362, 1000191062, 1000193585, 1000194476, 1000199414, 1000205660, 1000210937, 1000211803, 1000212626, 1000214335, 1000222495, 1000233193, 1000239650, 1000247182, 1000256556, 1000266164, 1000270836, 1000277104, 1000283590, 1000287393, 1000294080, 1000086193, 1000298088 |
|---|
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-2900-2018%22
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