Reported May 16, 2018 · Terminated
Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
Straumann Manufacturing, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Straumann Manufacturing, Inc. · 60 Minuteman Rd · Andover, MA · 01810-1008
Is this the product you have?
- Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
- Lot codes and dates
16 of 16 products
Products covered by this recall # Product as published 1 Lot LT830, Syringe Blister 2 Lot LK692B, Exp 5/31/2018 3 Lot LZ706, Syringe Blister 4 Lot LK692B, Exp 5/31/2018 5 Lot MG929, Syringe Blister 6 Lot LK692B, Exp 5/31/2018 7 Lot MT037, Syringe Blister 8 Lot MG253A, Exp 9/30/2018 9 Lot MZ441, Syringe Blister 10 Lot MG253A, Exp 9/30/2018 11 Lot NJ289, Syringe Blister 12 Lot MG253A, Exp 9/30/2018 13 Lot NJ579, Syringe Blister 14 Lot NA438A, Exp 3/31/2019 15 Lot NP340, Syringe Blister 16 Lot NA438A, Exp 3/31/2019 - Amount recalled
- 3046
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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 product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Straumann Manufacturing, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.