CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Straumann¿ Emdogain Multipack USA recalled by Straumann Manufacturing

Straumann Manufacturing is recalling Straumann¿ Emdogain Multipack USA, distributed nationwide in the US. The recall was initiated on 23 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot MZ538, Syringe Blister Lot MG253B, Exp 9/4/2018 Lot NJ580, Syringe Blister Lot MG253B, Exp 9/30/2018 Lot NK215, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot NP343, Syringe Blister Lot NE101A, Exp 3/31/2019

Quantity recalled2816

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1695-2018
FDA event ID: 79738
Recalling firm: Straumann Manufacturing, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 23 Mar 2018
FDA classified: 4 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Mar 2018	Recall initiated by company
4 May 2018	Classified by FDA	+42 days
16 May 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113

Where it was distributed

Distributed US Nationwide and Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Is Straumann¿ Emdogain Multipack USA recalled?

Yes. Straumann Manufacturing recalled Straumann¿ Emdogain Multipack USA on 23 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1695-2018.

Why was it 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.

Which lots are affected?

Lot MZ538, Syringe Blister Lot MG253B, Exp 9/4/2018 Lot NJ580, Syringe Blister Lot MG253B, Exp 9/30/2018 Lot NK215, Syringe Blister Lot NE101A, Exp 3/31/2019 Lot NP343, Syringe Blister Lot NE101A, Exp 3/31/2019

Where was it sold?

Distributed US Nationwide and Puerto Rico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Straumann Manufacturing

All 11

Reported	Class	Recall	Company	Reason	Where
21 Nov 2018Device	CLASS II	Neodent¿ GM Mini Conical Abutment recalled by Straumann Manufacturing	Straumann Manufacturing	Packaging Defects	Nationwide
16 May 2018Device	CLASS II	Straumann¿ Emdogain Enamel Matrix Derivative recalled	Straumann Manufacturing	Other	Nationwide
16 May 2018Device	CLASS II	Straumann¿ Emdogain Multipack USA recalled by Straumann Manufacturing	Straumann Manufacturing	Other	Nationwide
16 May 2018Device	CLASS II	Straumann¿ Emdogain Multipack recalled by Straumann Manufacturing	Straumann Manufacturing	Other	Nationwide
16 May 2018Device	CLASS II	Straumann¿ Emdogain Multipack recalled by Straumann Manufacturing	Straumann Manufacturing	Other	Nationwide

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