Z-2778-2020Class II

Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 -

Name: Z-2778-2020 Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 -
Creator: Anjon Holdings
Published: 2020-06-18
License: https://open.fda.gov/license/

G-5 Florida LLC / initiated 2020-06-18 / Terminated / root cause: design

FDA source

Anjon Holdings began a recall of Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener... on 2020-06-18. FDA classified it as Class II and gives the reason as "High rate of galling of one threaded component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2778-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-18
Posted: 2020-08-10
Terminated: 2020-11-25
Recalling firm: G-5 Florida LLC
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.
Product code: JEC Component, Traction, Invasive
Reason for recall: High rate of galling of one threaded component.
Root cause tag: design
FDA 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 the issue.
Quantity in commerce: 249 devices
Distribution: Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes.
Product codes and lots: REF number 100048 Lot # 170240, US customer Lot # 170162, 170163, 70164,170165, 170229, 170240, 170247, 170260 and SM 42048. International customers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2778-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2778-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-10

Product code JEC

K193256Class IIAnjon Bremer Halo SystemAnjon Holdings, LLC / cleared 2020-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)