Z-2910-2018 Class II Terminated
FDA device recall Z-2910-2018 was initiated by Stryker Leibinger GmbH & Co. KG on Jun 22, 2018 and is designated Class II. Reason for recall: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. The recall status is terminated (terminated Jul 8, 2019). Affected quantity: 22,831 total.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 5, 2018
- Initiation Date
- Jun 22, 2018
- Termination Date
- Jul 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,831 total
Product Description
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 for Recall
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Distribution Pattern
US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
Code Information
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,
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2910-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026