Straumann¿ Emdogain recall
Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
Why was Straumann¿ Emdogain recalled?
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
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?
Lot NY938, Syringe Blister Lot MN843, Exp 11/30/2018 Lot NP738, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot PG629, Syringe Blister Lot NK216, Exp 5/31/2019 Lot PY817, Syringe Blister Lot PT888C, Exp 1/31/2020
- Product
- Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
- Recalling firm
- Straumann Manufacturing, Inc.
- Quantity
- 2915
- Distribution
- Distributed US Nationwide and Puerto Rico.
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)