Recall Z-1518-2021— Omnia SRL

Class II FDA medical device recall by Omnia SRL, initiated 2021-03-30, terminated 2023-11-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. 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..

Recalling firm

Omnia SRL

Classification

Class II

Status

Terminated

Initiated

2021-03-30

Terminated

2023-11-08

Firm location

Fidenza, N/A, Italy

Data sourced from openFDA. This site is unofficial and independent of the FDA.