| 2025-06-25 |
Class II
|
Ongoing |
Z-2514-2025 |
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662 |
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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 th… |
| 2025-06-24 |
Class II
|
Ongoing |
Z-2107-2025 |
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only |
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Due to manufacturing error, digital analog rotational feature is 180 degrees off. |
| 2025-04-02 |
Class II
|
Ongoing |
Z-1987-2025 |
Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used i… |
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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… |
| 2024-06-25 |
Class II
|
Ongoing |
Z-2687-2024 |
Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straum… |
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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. |
| 2024-04-10 |
Class II
|
Ongoing |
Z-2318-2024 |
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous de… |
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Due to incorrect milled titanium abutment being packaged and labeled. |
| 2024-02-09 |
Class II
|
Ongoing |
Z-1321-2024 |
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967 |
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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… |
| 2023-07-18 |
Class II
|
Ongoing |
Z-0154-2024 |
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental |
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The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage |
| 2023-07-18 |
Class II
|
Ongoing |
Z-0153-2024 |
Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental |
— |
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage |
| 2023-07-18 |
Class II
|
Ongoing |
Z-0152-2024 |
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental |
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The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage |
| 2023-02-21 |
Class II
|
Ongoing |
Z-1285-2023 |
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 |
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Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommen… |
| 2023-02-01 |
Class III
|
Ongoing |
Z-1226-2023 |
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue… |
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Product is labeled with an incorrect expiration date. |