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Anjon Holdings recalls Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded
Recalled August 19, 2020 · FDA recall Z-2778-2020 · Anjon Holdings
Hazard
High rate of galling of one threaded component. · FDA Class II
Units
249 devices
Sold at
Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes.
Description
High rate of galling of one threaded component.
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.
Manufacturer(s)
Anjon Holdings
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →