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.
Reported: August 19, 2020 Initiated: June 18, 2020 #Z-2778-2020
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.
Details
- Recalling Firm
- Anjon Holdings
- Units Affected
- 249 devices
- Distribution
- Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes.
- Location
- Jacksonville, FL
Frequently Asked Questions
What product 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.. Recalled by Anjon Holdings. Units affected: 249 devices.
Why was this product recalled? ▼
High rate of galling of one threaded component.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 19, 2020. Severity: Moderate. Recall number: Z-2778-2020.
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