Recall Z-0368-2016— Merz North America, Inc.

Name: FDA recall Z-0368-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-26

Class II · Terminated

Class II FDA medical device recall by Merz North America, Inc., initiated 2015-10-26, terminated 2017-05-08. It names one FDA 510(k) clearance: K013243. Product: 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.. 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

510(k) clearances named in this recall

1 on FDA's record

K013243 — COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1Bioform, Inc.·cleared 2002-01-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.