Santa Maria, CA, United States
Preat Corp recalls
9 recalls recorded since 2018, most recently on 25 June 2025. 9 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)9
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 June 2025
- Reason
- Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
- Distribution
- US Nationwide distribution in the states of NY, FL, PA, CA, OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2514-2025
- NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Ongoing Class II Medical devices
- Recall started
- 24 June 2025
- Reason
- Due to manufacturing error, digital analog rotational feature is 180 degrees off.
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2107-2025
- Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Ongoing Class II Medical devices
- Recall started
- 2 April 2025
- Reason
- Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA, RI, TN,TX, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1987-2025
- Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support
Ongoing Class II Medical devices
- Recall started
- 25 June 2024
- Reason
- Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.
- Distribution
- U.S. Nationwide distribution in the states of AK, AZ, FL, GA, IL, LA, MD, MI, MN, NY, OH, OK, OR, PA, RI, TX, UT, and WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2687-2024
- Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Anal
Ongoing Class II Medical devices
- Recall started
- 10 April 2024
- Reason
- Due to incorrect milled titanium abutment being packaged and labeled.
- Distribution
- U.S.: CA, MO, and NV. O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2318-2024
- 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Ongoing Class II Medical devices
- Recall started
- 9 February 2024
- Reason
- Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
- Distribution
- U.S. Nationwide distribution in the states of AZ, OH and PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1321-2024
- Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Ongoing Class II Medical devices
- Recall started
- 18 July 2023
- Reason
- The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
- Distribution
- US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0152-2024, Z-0154-2024, Z-0153-2024
- Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
- Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
- Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Ongoing Class II Medical devices
- Recall started
- 21 February 2023
- Reason
- Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.
- Distribution
- US Nationwide distribution in the states of TX, OR, UT, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1285-2023
- Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Ongoing Class III Medical devices
- Recall started
- 1 February 2023
- Reason
- Product is labeled with an incorrect expiration date.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. There was also government distribution. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1226-2023
- PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.