Low Profile Screw — Class II medical device recall Z-1510-2020
Terminated recall by Arthrex, Inc., reported 2020-03-25, distributed in MA, MN, ND, OH, SD, TN. Screws provided in the device package are 6 mm longer than intended.
| Recall number | Z-1510-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2019-10-01 |
| Classified | 2020-03-17 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2021-09-08 |
| Distributed | MA, MN, ND, OH, SD, TN |
| Countries outside the US | AU, CN, KR |
| Quantity | 20 units |
| UPC / GTIN / UDI-DI | 00888867124424 |
| Lot numbers | 10308261 |
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 for recall
Screws provided in the device package are 6 mm longer than intended.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1510-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.