FDA recall Z-1510-2020

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-10-01

Report date

2020-03-25

Termination date

2021-09-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2020