Arthrex, Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Arthrex, Inc.
Lot Codes / Batch Numbers
Product Code: AR-8545-20, Batch Number: 10308261, UDI: 00888867124424
Products Sold
Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424
Arthrex, Inc. is recalling Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the due to Screws provided in the device package are 6 mm longer than intended.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Screws provided in the device package are 6 mm longer than intended.
Recommended Action
Per FDA guidance
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 complaints@arthrex.com. Arthrex agencies were directed to contact Arthrex Field Logistics Services at FLS@arthrex.com 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 complaints@arthrex.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MA, MN, ND, OH, SD, TN
Page updated: Jan 10, 2026