medical Class II Updated 2021-05-05

Omnia SRL recalls Omnia Soft Tissue Punch is a dental instrument designed to r

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: AK, IL, PA, OK, TX, UT, NY, CA
Lot/Code Info: Lot:118, 317, 319, 516, 616, 617, 618, 620, 716, 719, 720, 817, 818, 916, 920, 1016, 1018, 1216, 1217, 1316, 1317, 1318, 1319, 1418, 1516, 1618, 1718, 1720, 1816, 1817, 1918, 1919, 2018, 2117, 2118, 2119, 2216, 2316, 2319, 2416, 2417, 2619, 2713, 2717, 2718, 2719, 2816,2818, 2819, 2916, 3218, 3219, 3416, 3517,3716, 3719, 3816, 3818, 3916, 3917, 3918, 3919, 4118, 4217, 4220, 4318, 4320, 4416, 4417, 4419, 4617, 4715, 4716, 4816, 4819, 4820, 4915, 4920, 5118, 5319, 0317, 190B, 1920A, 1920B, 2518A, 2518B, 4820A
View official government recall

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