Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0368-2016·Announced 2015-12-09

Merz Recalls Prolaryn Plus Injectable Implant Due to Incorrect Expiration Date

Merz North America is recalling Prolaryn Plus Injectable Implants because the expiration date on the labels is incorrect. The recall covers 9,439 units distributed in the US and South Africa.

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 2/5 (Moderate).

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 and involves a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Merz North America, Inc. is recalling 9,439 units of PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. This medical device is an injectable implant used to treat vocal fold insufficiency.

The recall was initiated because the expiration date encoded in the UDI barcode on the product carton and the peelable patient identification label is incorrect. The affected units were distributed nationwide in the United States, including the Virgin Islands, as well as in South Africa.

Patients who have received this implant should contact their healthcare provider for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product: 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.
Manufacturer: Merz North America, Inc.
Category: Medical Device — Injectable Implant
Hazard: mis-labeling
Affected units: 9,439

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 (20)

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

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 2 recalled by Merz North America, 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 2 products in this recall →

Same manufacturer · Merz North America, Inc.

See all →

Low
Merz Recalls COAPTITE Injectable Implant Due to Documentation Mismatch
FDA (Devices) · 2020-11-25
Moderate
Merz Recalls Radiesse Injectable Implant Due to Syringe Delivery Issues
FDA (Devices) · 2016-08-31
Moderate
Merz Recalls Prolaryn Injectable Implant Due to Incorrect Expiration Date
FDA (Devices) · 2015-12-09
Moderate
Merz Recalls Radiesse Injectable Implant Due to Incorrect Expiration Date
FDA (Devices) · 2015-12-09

Same hazard · mis labeling