Accessories, Implant, Dental, Endosseous
Dental · 21 CFR 872.3980
Recent MDR events
4,902 adverse event reports on file
- Dental DriverJul 31, 2026MalfunctionZimvie Us Corp Llc0001038806-2026-04073
- TSV ANGLED SCREW CHANNEL DRIVER 30MMJul 31, 2026MalfunctionZimvie Us Corp Llc0001038806-2026-04075
- Unknown ATIS EV toolJul 31, 2026MalfunctionDentsply Implants Manufacturing Gmbh3013111692-2026-24423
- BioHorizons Conical Impression CopingJul 31, 2026MalfunctionBiohorizons Implant Systems1060818-2026-25533
- BioHorizons Internal 4.5mm Bulk Prep AbutmentJul 31, 2026MalfunctionBiohorizons Implant Systems1060818-2026-25535
- BioHorizons Conical Abutment screwJul 31, 2026MalfunctionBiohorizons Implant Systems1060818-2026-25534
- BioHorizons Internal Custom Cast AbutmentJul 31, 2026MalfunctionBiohorizons Implant Systems1060818-2026-25536
- GenTek¿ Hexalobular Screwdriver, 28 mmJul 30, 2026MalfunctionZfx Gmbh3008932779-2026-00034
- GenTek¿ Hexalobular Screwdriver, 28 mmJul 30, 2026MalfunctionZfx Gmbh3008932779-2026-00035
- MGUIDE sleeve dia.5.5 H 4mm (12 pack)Jul 30, 2026MalfunctionMis Implants Technologies Ltd.3004203816-2026-18944
Event type breakdown
Recalls
57 recall events for this product code
- Straumann USA LLCOpen, ClassifiedFeb 9, 2026
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Z-1337-2026 · View FDA record ↗ - Dentsply IH, Inc.Open, ClassifiedAug 25, 2025
Brand Name: Atlantis IO FLO-S
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
Z-2421-2025 · View FDA record ↗ - Dentsply IH, Inc.Open, ClassifiedAug 25, 2025
Brand Name: Atlantis IO FLO
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
Z-2422-2025 · View FDA record ↗ - Prismatik Dentalcraft, Inc.Open, ClassifiedMay 28, 2025
Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Z-1856-2025 · View FDA record ↗ - Straumann USA LLCOpen, ClassifiedApr 14, 2025
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
The devices are missing the laser marked depth markings.
Z-1561-2025 · View FDA record ↗ - TruAbutment Inc.Open, ClassifiedMar 11, 2025
Brand Name: TruScan Body, REF CN38-SB
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
Z-1313-2025 · View FDA record ↗ - Preat CorpOpen, ClassifiedAug 19, 2024
Multiple Digital Analog Products labeled as:
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.
Z-2687-2024 · View FDA record ↗ - Thommen Medical AGOpen, ClassifiedMar 20, 2024
impression coping, repositionable, short, screw-retained, PF 4.0
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Z-1322-2024 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1316-2020 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can b
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1317-2020 · View FDA record ↗
Registered firms
535 firms currently registered for this product code
Implant Concierge
San Antonio, TX, US
Keystone Industries
Myerstown, PA, US
Onvet Medical Canada Inc
TORONTO Ontario, CA
Aceso Dental Laboratory Company Limited
An Phuoc Ward Dong Nai, VN
Smart Denture Conversions, Llc
Apex, NC, US
Tri Dental Implants Direct Gmbh
Freiburg Baden-Wurttemberg, DE
Ards Industries Ltd
Petah Tikva Central, IL
Dof Inc
Seoul, KR
Cdm Center Of Excellence Ltd.
Beijing, CN
Avinent Implant System S.l.u.
Santpedor Barcelona, ES
Dental Direkt Gmbh
Spenge North Rhine-Westphalia, DE
Davis Dental Lab
Wyoming, MI, US
Medihub Co., Ltd.
Gunpo-si Gyeonggi, KR
Altatec Gmbh
WIMSHEIM Baden-Wurttemberg, DE
Pdt, Inc.
MSLA, MT, US
Rhein 83 Srl
BOLOGNA Emilia-Romagna, IT
Zuga Medical, Inc.
Cleveland, OH, US
Cendres+metaux Sa
Biel/Bienne Bern, CH
Straumann Manufacturing, Inc.
Mansfield, TX, US
Genoss Co., Ltd.
Suwon-si Gyeonggi, KR
Sterigenics U.s., Llc
Corona, CA, US
Medesy Srl
MANIAGO Pordenone, IT
Shandong Huge Dental Material Corporation
Rizhao Shandong, CN
Atria Co.
Seoul, KR
Kaiser Precision Co.
Hwaseong Gyeonggi, KR