Arthrex, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1510-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 1, 2019

Date Posted: March 25, 2020

Recall Number: Z-1510-2020

Event ID: 84030

Reason for Recall:

Screws provided in the device package are 6 mm longer than intended.

Status: Terminated

Product Quantity: 20 units

Code Information:

Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424

Distribution Pattern:

US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China

Voluntary or Mandated:

Voluntary: Firm initiated