Straumann Manufacturing, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1698-2018)

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 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W

Product Classification:

Class II

Date Initiated: March 23, 2018

Date Posted: May 16, 2018

Recall Number: Z-1698-2018

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: 1084

Code Information:

Lot NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018 Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019 Lot NP739, Syringe Blaster Lot NE101B, Exp 3/31/2019 Lot PY818, Syringe Blaster Lot PT888A, Exp 1/31/2020

Distribution Pattern:

Distributed US Nationwide and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated