Fidenza, N/A, Italy
Omnia SRL recalls
1 recall recorded since 2018, most recently on 30 March 2021. 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
- 30 March 2021
- Terminated
- 8 November 2023
- Reason
- Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016.
- Distribution
- Domestic: AK, IL, PA, OK, TX, UT, NY, CA. Foreign: Australia, Austria, Belgium, Bulgaria, Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Lebanon, Netherlands, New Zealand, Poland, Russia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, Uzbekistan, Canad
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1518-2021
- Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling
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.