Straumann¿ Emdogain recall
Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
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 LZ713, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MZ542, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MG933, Syringe Blaster Lot LP632B, Exp 6/30/2018 Lot MZ543, Syringe Blaster Lot MG253C, Exp 9/30/2018 Lot NJ581, Syringe Blaster Lot MG253C, Exp 9/30/2018 Lot NJ582, Syringe Blaster Lot NA438B, Exp 3/31/2019 Lot NP345, Syringe Blaster Lot NE101B, Exp 3/31/2019
- Product
- Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
- Recalling firm
- Straumann Manufacturing, Inc.
- Quantity
- 2356
- Distribution
- Distributed US Nationwide and Puerto Rico.
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)