Anika Therapeutics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2423-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 10, 2018

Date Posted: July 18, 2018

Recall Number: Z-2423-2018

Event ID: 80291

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.

Status: Terminated

Product Quantity: 1711

Code Information:

2017017A, 2017033A, 2017034A, 2017031A, 2017065A, 2017066A, 2017007A, 2017008A, 2017030A

Distribution Pattern:

US Nationwide Distribution in the state of IL.

Voluntary or Mandated:

Voluntary: Firm initiated