Straumann Manufacturing, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1693-2018)

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 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W

Product Classification:

Class II

Date Initiated: March 23, 2018

Date Posted: May 16, 2018

Recall Number: Z-1693-2018

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: 2381

Code Information:

Lot NP737, Syringe Blister Lot NA438A, Exp 3/31/2019; Lot PG628, Syringe Blister Lot NF819A, Exp 3/31/2019; Lot PY816, Syringe Blister Lot PT888C, Exp 1/31/2020; Lot NY939, Syringe Blister Lot, NA438A, Exp 3/31/2019

Distribution Pattern:

Distributed US Nationwide and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated