FDA Enforcement
Class II
Terminated
Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
Recall: Z-2244-2018
·
Reported June 27, 2018
Enforcement
- Recall Number
- Z-2244-2018
- Event ID
- 80198
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 27, 2018
- Initiation Date
- May 4, 2018
- Classification Date
- June 15, 2018
- Termination Date
- April 27, 2020
- Address
- Bohnackerweg 1, N/A, Selzach, N/A, N/A, Switzerland
Description
Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
Reason
Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm
Code Info
Lot # 04857V
Distribution
AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX
Quantity
18 parts (10 parts quarantined)