Recall Z-1518-2021 ยท EME Punch, Biopsy, Surgical
Omnia SRL
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.Z2020.0
| Date | Apr 29, 2021 (initiated Mar 30, 2021) |
| Status | Terminated |
| 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. |
| Root cause | Vendor change control |
| Action | On 03/30/2021, Omnia issued an Urgent Medical Device Removal notice via letter to customers notifying them Omnia has been made aware of a situation at a contract sterilization facility regarding inadequate or inappropriate sterilization processes being followed by employees of the contract sterilizer. |
| 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, Canad |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.