PROLARYN Injectable Implant 1 — Class II medical device recall Z-0367-2016
Terminated recall by Merz North America, Inc., reported 2015-12-09, distributed nationwide. The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient ide
| Recall number | Z-0367-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merz North America, Inc., Raleigh, NC, United States |
| Recall initiated | 2015-10-26 |
| Classified | 2015-12-03 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2017-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | ZA |
| Quantity | 7,715 units |
| Reason classes | labeling |
| Lot numbers | 100077099, 100077251, 100077252, 100077253, 100078692, 100079214, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932 |
| Model numbers | 8602M0K5 |
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.
Reason for recall
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0367-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.