Omnia SRL recalls Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue…

Recall date

March 30, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1518-2021

FDA classification

Class II

Brand / firm

Omnia SRL

Sold / distributed

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, Cana…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 and dental/orthodontic implant placement without the use of a scalpel. Model: 32.Z2000.00, 32.Z2002.00, 32.Z2004.00, 32.Z2006.00, 32.Z2007.00, 32.Z2008.00, 32.Z2009.00, 32.Z2020.00, 32.Z2022.00, 32.Z2024.00, 32.Z2026.00, 32.Z2027.00, 32.Z2028.00, 32.Z2030.00, 32.Z2032.00, 32.Z2034.00, 32.Z2036.00, 32.Z2038.00, 32.Z2040.00, 72.T1950.00, 72.T1951.00, 72.T1952.00, 72.T1953.00