Bedford, MA, United States
Anika Therapeutics, Inc. recalls
1 recall recorded since 2018, most recently on 10 May 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 May 2018
- Terminated
- 10 May 2019
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2423-2018
- 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 o
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.