FDA recall Z-1518-2021

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 for recall

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, Canada, Malta,

Key facts

Status

Terminated

Initiation date

2021-03-30

Report date

2021-05-05

Termination date

2023-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fidenza, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1518-2021