Z-2905-2018 Class II Terminated
FDA device recall Z-2905-2018 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
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, 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
1000181748, 1000295062
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2905-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026