| Class 2 Device Recall PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KHJ
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