PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstruct
FDA device recall Z-0367-2016 · posted 2015-12-03 · Terminated
Recall details
- Recalling firm
- Merz North America, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIX
- Quantity affected
- 7,715 units
- Distribution
- Distributed US (nationwide) including the Virgin Islands and South Africa.
- Date initiated
- 2015-10-26
- Date posted
- 2015-12-03
- Date terminated
- 2017-05-08
- Location
- Raleigh, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (K060815) | Bioform Medical, Inc. | 2006-04-18 |