Omnia Soft Tissue Punch is a dental instrument designed recall
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)…
Why was Omnia Soft Tissue Punch is a dental instrument designed 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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)…
- Recalling firm
- Omnia SRL
- Quantity
- 276,901 units
- 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,
- Recall date
- May 5, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)