Axiom 2.8 implants Sterile The Axiom REG implants are recall
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…
Why was Axiom 2.8 implants Sterile The Axiom REG implants are recalled?
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Code OP28100 Size 02.8 x 10.0 Code OP28120 Size 02.8 x 12.0 Code OP28140 Size 02.8 x 14.0
- Product
- 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…
- Recalling firm
- Anthogyr
- Quantity
- 10 units
- Distribution
- US Distribution to sates of: NC, NY, and OR.
- Recall date
- September 14, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)