Anjon Bremer Molded Crown recalled over mold contamination

Recall date

June 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Anjon Holdings recalls Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded…

Recall number

Z-2778-2020

FDA classification

Class II

Brand / firm

Anjon Holdings

Sold / distributed

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

Why it was recalled

High rate of galling of one threaded component.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.