The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0367-2016·Announced 2015-12-09

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.

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, 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

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 →

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