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.
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 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.
- Hazard
- 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
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 →Related recalls
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- ModerateMerz Recalls Prolaryn Injectable Implant Due to Incorrect Expiration Date
FDA (Devices) · 2015-12-09
- ModerateMerz Recalls Radiesse Injectable Implant Due to Incorrect Expiration Date
FDA (Devices) · 2015-12-09
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