Z-1510-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- October 1, 2019
- Termination Date
- September 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
Reason for Recall
Screws provided in the device package are 6 mm longer than intended.
Distribution Pattern
US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
Code Information
Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424