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U.S. Department of Health and Human Services

Class 2 Device Recall Hyalomatrix

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  Class 2 Device Recall Hyalomatrix see related information
Date Initiated by Firm May 10, 2018
Create Date July 11, 2018
Recall Status1 Terminated 3 on May 10, 2019
Recall Number Z-2423-2018
Recall Event ID 80291
510(K)Number K073251  
Product Classification Dressing, wound, drug - Product Code FRO
Product Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301

Product Usage:
Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that acts as an advanced wound care device. It is comprised of a non-woven pad entirely composed of HY AFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFFl 1 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth. Hyalomatrix is indicated for the management of wounds including: partial and full-thickness wounds; second-degree bums; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.
Code Information 2017017A, 2017033A, 2017034A, 2017031A, 2017065A, 2017066A, 2017007A, 2017008A, 2017030A
Recalling Firm/
Manufacturer		 Anika Therapeutics, Inc.
32 Wiggins Ave
Bedford MA 01730-2315
For Additional Information Contact
781-457-9000
Manufacturer Reason
for Recall		 Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization, which resulted in degradation of the film. Over the long term it is possible that product integrity may be compromised.
FDA Determined
Cause 2		 Package design/selection
Action On May 10, 2018, the firm notified its affected distributor via emailed memorandum of its voluntary recall. The distributor was informed of the affected lots and quantities, and asked to discontinue distribution and sales activities related the affected products.
Quantity in Commerce 1711
Distribution US Nationwide Distribution in the state of IL.
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 = FRO and Original Applicant = FIDIA ADVANCED BIOPOLYMERS SRL
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