Straumann Manufacturing, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1694-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099

Product Classification:

Class II

Date Initiated: March 23, 2018

Date Posted: May 16, 2018

Recall Number: Z-1694-2018

Event ID: 79738

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.

Status: Terminated

Product Quantity: 3046

Code Information:

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

Distribution Pattern:

Distributed US Nationwide and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated