Recall Z-0367-2016 ยท MIX System, Vocal Cord Medialization
Merz North America, Inc.
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.
| Date | Dec 3, 2015 (initiated Oct 26, 2015) |
| 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 7,715 units |
| Distribution | Distributed US (nationwide) including the Virgin Islands and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060815 | JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT Bioform Medical, Inc., Apr 18, 2006 |