Recall Z-0367-2016— Merz North America, Inc.
Class II · Terminated
Class II FDA medical device recall by Merz North America, Inc., initiated 2015-10-26, terminated 2017-05-08. 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: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect..
- Recalling firm
- Merz North America, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-26
- Terminated
- 2017-05-08
- Firm location
- Raleigh, NC, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.