CLASS II Device recall · Reported 9 Dec 2015 · FDA Enforcement Report

Prolaryn Plus Injectable Implant 0 cc Plus Calcium recalled

Merz North America is recalling Prolaryn Plus Injectable Implant 0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable, distributed nationwide in the US. The recall was initiated on 26 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 100076901, 100077013, 100077249, 100077250, 100078691, 100079054, 100079213, 100079597, 100079954, 100080082, 100081008, 100081401, 100081573, 100081916, 100082248, 100082468, 100082695, 100082729, 100083126, 100083785, 100083934

Quantity recalled9,439 units

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-0368-2016
FDA event ID: 72591
Recalling firm: Merz North America, Raleigh, NC
Classification: Class II
Status: Terminated
Recall initiated: 26 Oct 2015
FDA classified: 3 Dec 2015
Reported: 9 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Oct 2015	Recall initiated by company
3 Dec 2015	Classified by FDA	+38 days
9 Dec 2015	Published in enforcement report	+6 days

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

Reason for recall

The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

Product as listed by the FDA

PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.

Where it was distributed

Distributed US (nationwide) including the Virgin Islands and South Africa.

Nationwide

Questions about this recall

Is Prolaryn Plus Injectable Implant 0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable recalled?

Yes. Merz North America recalled Prolaryn Plus Injectable Implant 0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable on 26 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0368-2016.

Why was it recalled?

The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

Which lots are affected?

Lot Number 100076901, 100077013, 100077249, 100077250, 100078691, 100079054, 100079213, 100079597, 100079954, 100080082, 100081008, 100081401, 100081573, 100081916, 100082248, 100082468, 100082695, 100082729, 100083126, 100083785, 100083934

Where was it sold?

Distributed US (nationwide) including the Virgin Islands and South Africa.

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 Merz North America

All 5

Reported	Class	Recall	Company	Reason	Where
25 Nov 2020Device	CLASS II	Coaptite Injectable Implant, injectable, sterile recalled	Merz North America	Particulate Matter	48 states
31 Aug 2016Device	CLASS II	Radiesse (+) Lidocaine, Injectable Implant 5cc recalled	Merz North America	Other	Nationwide
9 Dec 2015Device	CLASS II	Prolaryn Injectable Implant 0 cc Gel recalled by Merz North America	Merz North America	Other	Nationwide
9 Dec 2015Device	CLASS II	Radiesse (+) Lidocaine Injectable Implant 5cc recalled	Merz North America	Other	Nationwide

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