FDAFDA · Food and drugs·Recall number Z-1694-2018
Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
Published May 16, 2018 · Recall initiated: March 23, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Straumann Manufacturing, Inc.
- Distributor
- Distributed US Nationwide and Puerto Rico.
- Lot
- Lot LT830, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot LZ706, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MG929, Syringe Blister Lot LK692B, Exp 5/31/2018 Lot MT037, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot MZ441, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ289, Syringe Blister Lot MG253A, Exp 9/30/2018 Lot NJ579, Syringe Blister Lot NA438A, Exp 3/31/2019 Lot NP340, Syringe Blister Lot NA438A, Exp 3/31/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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