Reported May 5, 2021 · Terminated
Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue…
Omnia SRL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Omnia SRL · Via Fratelli Cairoli 5 · Fidenza, N/A · N/A
Is this the product you have?
- 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.Z2000.0032.Z2002.0032.Z2004.0032.Z2006.0032.Z2007.0032.Z2008.0032.Z2009.0032.Z2020.0032.Z2022.0032.Z2024.0032.Z2026.0032.Z2027.0032.Z2028.0032.Z2030.0032.Z2032.0032.Z2034.0032.Z2036.0032.Z2038.0032.Z2040.0072.T1950.0072.T1951.0072.T1952.0072.T1953.00
- Lot codes and dates
- Lot
87 of 87 codes
118317319516616617618620716719720817818916920101610181216121713161317131813191418151616181718172018161817191819192018211721182119221623162319241624172619271327172718271928162818281929163218321934163517371637193816381839163917
- Lot
- Amount recalled
- 276,901 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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