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U.S. Department of Health and Human Services

Class 2 Device Recall PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant

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  Class 2 Device Recall PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant see related information
Date Initiated by Firm October 26, 2015
Date Posted December 03, 2015
Recall Status1 Terminated 3 on May 08, 2017
Recall Number Z-0368-2016
Recall Event ID 72591
510(K)Number K013243  
Product Classification Polymer, ent synthetic-polyamide (mesh or foil material) - Product Code KHJ
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.
Code Information Lot Number 100076901, 100077013, 100077249, 100077250, 100078691, 100079054, 100079213, 100079597, 100079954, 100080082, 100081008, 100081401, 100081573, 100081916, 100082248, 100082468, 100082695, 100082729, 100083126, 100083785, 100083934
Recalling Firm/
Manufacturer		 Merz North America, Inc.
6501 Six Forks Rd
Raleigh NC 27615-6515
For Additional Information Contact
866-862-8211
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 9,439 units
Distribution Distributed US (nationwide) including the Virgin Islands and South Africa.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KHJ and Original Applicant = BIOFORM, INC.
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