FDA Device recall Z-2904-2018
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, 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 DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, 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-2904-2018 |
| 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 DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, 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 | 1000107793, 1000107794, 1000107795, 1000111407, 1000113293, 1000119681, 1000119682, 1000124116, 1000130031, 1000134145…1000107793, 1000107794, 1000107795, 1000111407, 1000113293, 1000119681, 1000119682, 1000124116, 1000130031, 1000134145, 1000139203, 1000141585, 1000148808, 1000150571, 1000156031, 1000159892, 1000166365, 1000168534, 1000169198, 1000170705, 1000171359, 1000174838, 1000176391, 1000183609, 1000188544, 1000189237, 1000191063, 1000193586, 1000195789, 1000202429, 1000215159, 1000217674, 1000220165, 1000224225, 1000231906, 1000233773, 1000236827, 1000239654, 1000245176, 1000251377, 1000254803, 1000262514 |
|---|
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-2904-2018%22
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