# FDA recall Z-2423-2018

> **Anika Therapeutics, Inc.** · Class II · device recall initiated 2018-05-10.

## 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

## 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.

## Distribution

US Nationwide Distribution in the state of IL.

## Key facts

- **Recall number:** Z-2423-2018
- **Recalling firm:** Anika Therapeutics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-10
- **Report date:** 2018-07-18
- **Termination date:** 2019-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bedford, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2423-2018

## Citation

> AI Analytics. FDA recall Z-2423-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2423-2018. Source: US FDA. Licensed CC0.

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