Z-1697-2018 Class II Terminated
FDA device recall Z-1697-2018 was initiated by Straumann Manufacturing, Inc. on March 23, 2018 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 2, 2019). Affected quantity: 2356.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- March 23, 2018
- Termination Date
- May 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2356
Product Description
Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
Reason for Recall
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.
Distribution Pattern
Distributed US Nationwide and Puerto Rico.
Code Information
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