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.
FDA Recall Z-2778-2020 · Posted None
Advertisement
Recalling FirmAnjon Holdings
Recall StatusTerminated
Product CodeJEC
Date Initiated2020-06-18
Date Terminated2020-11-25
Product Quantity249 devices
Reason for Recall
High rate of galling of one threaded component.
Firm Action
The one unit released into the United States has already been returned, unused, to Anjon. No uncorrected product remains in distribution or in use in the USA.
No units subject to the failure mode have been released into distribution within Japan. All units shipped to Japan are being either returned to Anjon for reprocessing to remove the failure mode; or are to corrected by the addition of the instruction to use sterile surgical lubricant on the thread of the Slider. JMDM is the license holder for the product within Japan and will not release the product until resolution to its satisfaction of the issue.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement