PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5.… recallZ-0367-2016 · Merz North America, Inc. · initiated Oct 26, 2015
Class II Terminated All recalls posted in December 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merz North America, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
FDA root cause category: Other
What the company is doing
Letters were issued 11/4/2015 to consignees. The letter informs the consignees that they can continue to safely use the affected products by referring to the USE BEFORE date. They letter does not require for any product to be returned. Also, there is no sub-recall required as the product was not distributed to distributors or wholesalers.
Recall details
- Recall number
- Z-0367-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 26, 2015
- Posted by the FDA
- Dec 3, 2015
- Recalling firm
- Merz North America, Inc.
- Quantity
- 7,715 units
- Product code
- MIX
- FDA submissions
- K060815
- Distribution
- Distributed US (nationwide) including the Virgin Islands and South Africa.
Product description
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.
Code information (models, lots, serial numbers)
Lot Number 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932
Other devices under the same FDA submission
1 device cleared under K060815 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Prolaryn Gel Injectable Implant 8602M0K5Merz North America, Inc. · System, Vocal Cord Medialization1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 72591).
- Z-0368-2016 · TerminatedPROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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