FDA Device recall Z-1510-2020
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 intend…
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of 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 intend… by Arthrex, citing screws provided in the device package are 6 mm longer than intended.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1510-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-01 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Arthrex |
| Distribution | MA, MN, ND, OH, SD, TN |
Product
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.
Identifiers
| code_info | Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1510-2020%22
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