Merz Recalls Prolaryn Injectable Implant Due to Incorrect Expiration Date
Merz North America is recalling Prolaryn Injectable Implant 1.0 cc Gel because the expiration date on the label is incorrect.
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, which typically indicates a temporary or medically reversible adverse health consequence. The specific issue is an incorrect expiration date, which is a labeling error rather than a direct product defect causing injury.
Plain-English summary
Merz North America, Inc. is recalling 7,715 units of PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. This product is a restorable implant material used in laryngeal surgical procedures for vocal fold medialization and augmentation. The recall is due to an incorrect expiration date encoded in the UDI barcode on the product carton and the peelable patient identification label.
The affected units were distributed nationwide in the United States, including the Virgin Islands, as well as in South Africa. The recall covers specific lot numbers: 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, and 100083932.
Healthcare providers and patients should check the lot numbers and expiration dates on their Prolaryn Injectable Implant products. If the product matches the recalled lots, it should not be used. Contact Merz North America, Inc. for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
- Manufacturer
- Merz North America, Inc.
- Category
- Medical Device — Implants
- Hazard
- Affected units
- 7,715
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 (15)
- Lot Number 100079214
- 100077099
- 100077251
- 100077252
- 100077253
- 100078692
- 100079598
- 100080204
- 100081409
- 100081577
- 100082304
- 100082438
- 100083371
- 100083875
- 100083932
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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