FDA Enforcement
Class II
Terminated
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.
Recall: Z-1510-2020
·
Reported March 25, 2020
Enforcement
- Recall Number
- Z-1510-2020
- Event ID
- 84030
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arthrex, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- March 25, 2020
- Initiation Date
- October 1, 2019
- Classification Date
- March 17, 2020
- Termination Date
- September 8, 2021
- Address
- 1370 Creekside Blvd, Naples, FL, 34108-1945, United States
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
Screws provided in the device package are 6 mm longer than intended.
Code Info
Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424
Distribution
US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
Quantity
20 units