Z-2423-2018Class II

Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301

Name: Z-2423-2018 Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301
Creator: Anika Therapeutics, Inc.
Published: 2018-05-10
License: https://open.fda.gov/license/

Anika Therapeutics, Inc. / initiated 2018-05-10 / Terminated / root cause: packaging

FDA source

Anika Therapeutics, Inc. began a recall of Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable wound dressing that... on 2018-05-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2423-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-10
Posted: 2018-07-11
Terminated: 2019-05-10
Recalling firm: Anika Therapeutics, Inc.
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.
Product code: FRO Dressing, Wound, Drug
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.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: 2017017A, 2017033A, 2017034A, 2017031A, 2017065A, 2017066A, 2017007A, 2017008A, 2017030A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2423-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2423-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-11

Product code FRO

K073251UnclassifiedHyalomatrix PaFidia Advanced Biopolymers Srl / cleared 2007-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)