The Recall Desk
HighFDA (Devices)·Z-1697-2018·Announced 2018-05-16

Straumann Emdogain Recalled for Unverified Raw Material Shelf Life Change

Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of data demonstrating continued efficacy, which fits the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Straumann Manufacturing, Inc. is recalling Straumann Emdogain 0.7 ml Multipack USA (Article Number 075.115). The recall involves 2,356 units distributed nationwide in the United States and Puerto Rico.

The recall was initiated because 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. This is classified as an FDA Class II recall.

Affected lots include LZ713, MZ542, MG933, MZ543, NJ581, NJ582, and NP345, with expiration dates ranging from June 30, 2018, to March 31, 2019. Consumers and healthcare providers should stop using the product and contact Straumann Manufacturing for further instructions.

The recalled product

Product
Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
Manufacturer
Straumann Manufacturing, Inc.
Category
Medical Device — Dental
Hazard
Affected units
2,356

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Lot LZ713
  • Syringe Blaster Lot LP632B
  • Exp 6/30/2018 Lot MZ542
  • Exp 6/30/2018 Lot MG933
  • Exp 6/30/2018 Lot MZ543
  • Syringe Blaster Lot MG253C
  • Exp 9/30/2018 Lot NJ581
  • Exp 9/30/2018 Lot NJ582
  • Syringe Blaster Lot NA438B
  • Exp 3/31/2019 Lot NP345
  • Syringe Blaster Lot NE101B
  • Exp 3/31/2019

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Straumann Manufacturing, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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