Recall Z-2778-2020— Anjon Holdings
Class II · Terminated
Class II FDA medical device recall by Anjon Holdings, initiated 2020-06-18, terminated 2020-11-25. It names one FDA 510(k) clearance: K193256. 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: High rate of galling of one threaded component..
- Recalling firm
- Anjon Holdings
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-18
- Terminated
- 2020-11-25
- Firm location
- Jacksonville, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.