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Recall Observatory FDA recall evidence

Device 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.

Z-2778-2020

June 18, 2020

Class II

Product summary

Firm
Anjon Holdings
Event
Event 85958
Status
Terminated
Classification
Class II
Quantity
249 devices
Official record key
device-enforcement:Z-2778-2020

Official wording

Reason: High rate of galling of one threaded component.

Code information: REF number 100048 Lot # 170240, US customer Lot # 170162, 170163, 70164,170165, 170229, 170240, 170247, 170260 and SM 42048. International customers.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    High rate of galling of one threaded component.