Z-1518-2021Class II

Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral...

Name: Z-1518-2021 Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral...
Creator: Omnia SRL
Published: 2021-03-30
License: https://open.fda.gov/license/

Omnia SRL / initiated 2021-03-30 / Terminated / root cause: supplier

FDA source

Omnia SRL began a recall of 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... on 2021-03-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1518-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-30
Posted: 2021-04-29
Terminated: 2023-11-08
Recalling firm: Omnia SRL
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
Product code: EME Punch, Biopsy, Surgical
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.
Root cause tag: supplier
FDA 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 in commerce: 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,
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1518-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1518-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-29

Product code EME

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)