🔍 RecallPedia

Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.

Class I - Dangerous
🏥 Medical Devices Recalled: June 20, 2016 Anthogyr Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Code OP34080 Size 03.4 x 8.0 Code OP34100 Size 03.4 x 10.0 Code OP34120 Size 03.4 x 12.0 Code OP34140 Size 03.4 x 14.0 Code OP34160 Size 03.4 x 16.0 Code OP34180 Size 03.4 x 18.0 Code OP40060 Size 04.0 x 6.5 Code OP40080 Size 04.0 x 8.0 Code OP40100 Size 04.0 x 10.0 Code OP40120 Size 04.0 x 12.0 Code OP40140 Size 04.0 x 14.0 Code OP40160 Size 04.0 x 16.0 Code OP40180 Size 04.0 x 18.0 Code OP46060 Size 04.6 x 6.5 Code OP46080 Size 04.6 x 8.0 Code OP46100 Size 04.6 x 10 Code OP46120 Size 04.6 x 12 Code OP46140 Size 04.6 x 14 Code OP52060 Size 05.2 x 6.5 Code OP52080 Size 05.2 x 8.0 Code OP52100 Size 05.2 x 10.0 Code OP52120 Size 05.2 x 12.0 Code OP52140 Size 05.2 x 14.0
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Anthogyr
Reason for Recall:
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.

Product Codes/Lot Numbers:

Code OP34080 Size 03.4 x 8.0 Code OP34100 Size 03.4 x 10.0 Code OP34120 Size 03.4 x 12.0 Code OP34140 Size 03.4 x 14.0 Code OP34160 Size 03.4 x 16.0 Code OP34180 Size 03.4 x 18.0 Code OP40060 Size 04.0 x 6.5 Code OP40080 Size 04.0 x 8.0 Code OP40100 Size 04.0 x 10.0 Code OP40120 Size 04.0 x 12.0 Code OP40140 Size 04.0 x 14.0 Code OP40160 Size 04.0 x 16.0 Code OP40180 Size 04.0 x 18.0 Code OP46060 Size 04.6 x 6.5 Code OP46080 Size 04.6 x 8.0 Code OP46100 Size 04.6 x 10 Code OP46120 Size 04.6 x 12 Code OP46140 Size 04.6 x 14 Code OP52060 Size 05.2 x 6.5 Code OP52080 Size 05.2 x 8.0 Code OP52100 Size 05.2 x 10.0 Code OP52120 Size 05.2 x 12.0 Code OP52140 Size 05.2 x 14.0

Distribution:

Distributed in: US, NC, NY, OR

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2753-2016

Related Recalls

Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.

Anthogyr

Class I - Dangerous

Following a FDA inspection showing that the firm failed to validate the design and process of its implants.

Jun 20, 2016 Implants & Prosthetics View Details →