Recall Z-0368-2016 ยท KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Merz North America, Inc.
PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
| 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 | 9,439 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
| K013243 | COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 Bioform, Inc., Jan 9, 2002 |