FDA recall Z-2778-2020

Product

Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.

Reason for recall

High rate of galling of one threaded component.

Distribution

Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes.

Key facts

Status

Terminated

Initiation date

2020-06-18

Report date

2020-08-19

Termination date

2020-11-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jacksonville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2778-2020