Class II — Merz North America, Inc.
| Recalling firm | Merz North America, Inc. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. |
| 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. |
| Quantity | 7,715 units |
| Distribution | Distributed US (nationwide) including the Virgin Islands and South Africa. |
| Initiated | 2015-10-26 |
| Classified | 2015-12-03 |
| Terminated | 2017-05-08 |
| Recall number | Z-0367-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merz North America, Inc. (Z-0367-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72591/
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