FDA Enforcement
Class II
Terminated
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
Recall: Z-2905-2018
·
Reported September 5, 2018
Enforcement
- Recall Number
- Z-2905-2018
- Event ID
- 80371
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Leibinger GmbH & Co. KG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 5, 2018
- Initiation Date
- June 22, 2018
- Classification Date
- August 29, 2018
- Termination Date
- July 8, 2019
- Address
- Botzinger Str. 41, N/A, Freiburg Im Breisgau, N/A, N/A, Germany
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
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Code Info
1000181748, 1000295062
Distribution
US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
Quantity
22,831 total