Low Profile Screw, 4.5 x 20 mm recallZ-1510-2020 · Arthrex, Inc. · initiated Oct 1, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arthrex, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Screws provided in the device package are 6 mm longer than intended.
FDA root cause category: Employee error
What the company is doing
Arthrex notified customers of the recall on about 10/01/2019, via "URGENT: REMOVAL NOTIFICATION" letter. Customers were informed that the Low Profile Screw, labeled as 4.5 x 20 mm, in their package measures 6 mm longer than intended. Customers were instructed to immediately discontinue use, sale, and distribution of affected screws and to acknowledge receipt of the recall notification. Direct customers were directed to contact Anthrex Product Surveillance at 866-267-9138 or [email protected]. Arthrex agencies were directed to contact Arthrex Field Logistics Services at [email protected] as soon as possible to arrange for return of affected products. An email also accompanied the recall letter and requested that customers return all affected product. Questions can be addressed to Arthrex Product Surveillance at 866-267-9138 or [email protected].
Recall details
- Recall number
- Z-1510-2020
- Status
- Terminated
- Initiated by the company
- Oct 1, 2019
- Recalling firm
- Arthrex, Inc.
- Quantity
- 20 units
- Product code
- HWC
- FDA submissions
- K141735
- Distribution
- US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
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.
Code information (models, lots, serial numbers)
Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Arthrex® AR-8545-20Arthrex, Inc. · PLATE, FIXATION, BONE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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