The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1694-2018·Announced 2018-05-16

Straumann Emdogain Recall Due to Shelf Life Data Issue

Straumann Manufacturing is recalling specific lots of Emdogain because a raw material shelf life change was made without data proving the product remains effective.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 product is a medical device with a potential efficacy failure (risk of harm) where injury has not yet been reported, fitting the 'High' criteria. It is an FDA Class II recall, which typically aligns with High severity when there is a risk of harm but no reported illness.

Plain-English summary

Straumann Manufacturing, Inc. is recalling specific lots of Straumann Emdogain 015, an Enamel Matrix Derivative used in dental procedures. The recall affects 3,046 units distributed nationwide and in Puerto Rico.

The reason for the recall is that a change regarding the shelf life of a raw material was implemented without submitting appropriate data to demonstrate that the product continues to be effective. Affected lots include LT830, LZ706, MG929 (Syringe Blister Lot LK692B), MT037, MZ441, NJ289 (Syringe Blister Lot MG253A), and NJ579, NP340 (Syringe Blister Lot NA438A).

Consumers and healthcare providers should check their inventory against the listed lot numbers. The FDA has classified this recall as Class II.

The recalled product

Product
Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
Manufacturer
Straumann Manufacturing, Inc.
Category
Medical Device — Enamel Matrix Derivative
Hazard
Affected units
3,046

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 LT830
  • Syringe Blister Lot LK692B
  • Exp 5/31/2018 Lot LZ706
  • Exp 5/31/2018 Lot MG929
  • Exp 5/31/2018 Lot MT037
  • Syringe Blister Lot MG253A
  • Exp 9/30/2018 Lot MZ441
  • Exp 9/30/2018 Lot NJ289
  • Exp 9/30/2018 Lot NJ579
  • Syringe Blister Lot NA438A
  • Exp 3/31/2019 Lot NP340
  • 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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