Recall Z-2778-2020 ยท JEC Component, Traction, Invasive
Anjon Holdings
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.
| Date | Jun 18, 2020 |
| Status | Terminated |
| Reason | High rate of galling of one threaded component. |
| Root cause | Device Design |
| 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 |
| Quantity | 249 devices |
| Distribution | Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193256 | Anjon Bremer Halo System Anjon Holdings, LLC, Mar 2, 2020 |