Anjon Bremer Molded Crown Spinal Fixation Fastener: High Galling Risk

Take action

Contact the company & request your remedy

Recalling firmAnjon Holdings4801 Dawin Rd, N/A · Jacksonville, FL 32207-9512

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Anjon is recalling specific spinal fixation fasteners (REF 100048) because threaded components can gall at a high rate. This could lead to improper spinal fixation during surgery, potentially causing complications for patients.

Why it’s dangerous

Galling occurs when metal surfaces rub together excessively, causing the threaded component to wear down or stick. This can lead to improper spinal fixation during surgery, potentially causing complications for patients.

Who’s affected

Patients receiving spinal surgery using the recalled Anjon Bremer Molded Crown fasteners are most at risk. Medical professionals using these devices for cervical spine immobilization may also be affected.

How to tell if you have this one

Check for the REF number 100048 on the device. Affected units include specific lot numbers: 170240, 170162, 170163, 70164, 170165, 170229, 170240, 170247, 170260, and SM 42048. These were sold in the US and internationally.

Brand
Anjon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for the lot numbers listed: 170240, 170162, 170163, 70164, 170165, 170229, 170240, 170247, 170260, and SM 42048.
Contact Manufacturer
Reach out to Anjon Holdings for guidance on next steps if you have the recalled device.

✎ GovInfoNow

Questions people ask

What is the hazard with the recalled spinal fasteners?

The hazard is a high rate of galling in one threaded component, which can lead to improper spinal fixation during surgery.

Which lot numbers are affected?

Affected lot numbers include 170240, 170162, 170163, 70164, 170165, 170229, 170240, 170247, 170260, and SM 42048.

Do I need to stop using the device immediately?

No, but you should check the lot number and contact Anjon Holdings if you have the recalled device.

Take action

Contact Anjon

We’ve drafted a message you can send Anjon to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2778-2020 — Anjon Anjon

Hello,

I own a Anjon that is covered by recall Z-2778-2020 from Anjon.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2778-2020 (June 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2778-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Anjon Holdings recalls Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded

Use caution until it’s fixed