The Recall Desk
ModerateFDA (Devices)·Z-1698-2018·Announced 2018-05-16

Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

Straumann Manufacturing is recalling Emdogain 0.7 ml Multipacks because a raw material shelf life change was implemented without submitting data to demonstrate continued product efficacy.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a procedural failure regarding data submission for efficacy rather than a confirmed safety hazard, contamination, or reported injury. This aligns with the 'Moderate' criteria for voluntary precautionary recalls or minor issues where no immediate harm is reported.

Plain-English summary

Straumann Manufacturing, Inc. is recalling Straumann Emdogain 0.7 ml Multipack, an Enamel Matrix Derivative (Article Number 075.116W). The recall involves 1,084 units distributed nationwide in the United States and Puerto Rico. Specific affected lots include NZ535, PG631, NP739, and PY818, with expiration dates ranging from June 30, 2018, to January 31, 2020.

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 procedural issue raises concerns about the product's performance and safety profile.

Healthcare professionals and patients who have used or possess these specific lots should contact Straumann Manufacturing for further instructions on how to return the product or obtain a replacement. Consumers should not use the recalled product until further notice.

The recalled product

Product
Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
Manufacturer
Straumann Manufacturing, Inc.
Category
Medical Device — Dental / Oral Health
Hazard
Affected units
1,084

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 (9)

  • 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

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 →

Related recalls

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