Implant, Endosseous, Root-form
Dental · 21 CFR 872.3640
Recent MDR events
3,864,627 adverse event reports on file
- OsseoSpeed TX 3.0 S - 11 mmJul 31, 2026InjuryDentsply Implants Manufacturing Gmbh3013111692-2026-24413
- PrimeTaper EV Ø4.2 x 11mm OSJul 31, 2026InjuryDentsply Implants (a Division Of Dentsply Ih Ab)9612468-2026-03784
- Unknown Ankylos abutmentJul 31, 2026InjuryDentsply Implants Manufacturing Gmbh3013111692-2026-23664
- SEVEN XD int. hex. implant D3.75 L10mm SPJul 31, 2026InjuryMis Implants Technologies Ltd.3004203816-2026-18537
- Eztetic Dental Implant, 3.1mm Diameter, 2.9mmD Platform, 11.5mm LengthJul 31, 2026InjuryZimvie Us Corp Llc0001038806-2026-04043
- OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 10MMJul 31, 2026InjuryZimvie Us Corp Llc0001038806-2026-04044
- iSy Implant-Set Promote plusJul 31, 2026InjuryAltatec Gmbh9613866-2026-58231
- Camlog Screw-Line Implant PromoteJul 31, 2026InjuryAltatec Gmbh9613866-2026-57195
- Camlog Screw-Line Implant PromoteJul 31, 2026InjuryAltatec Gmbh9613866-2026-57200
- Camlog Screw-Line Implant PromoteJul 31, 2026InjuryAltatec Gmbh9613866-2026-57205
Event type breakdown
Recalls
211 recall events for this product code
- Straumann USA LLCOpen, ClassifiedAug 11, 2026
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
Z-2935-2026 · View FDA record ↗ - S.I.N. Implant System LtdaOpen, ClassifiedOct 1, 2025
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N;
Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.
Z-0017-2026 · View FDA record ↗ - Straumann USA LLCOpen, ClassifiedMay 28, 2025
GM Helix Acqua Implant, Article Number: 140.984
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Z-1862-2025 · View FDA record ↗ - Straumann USA LLCOpen, ClassifiedMay 28, 2025
GM Helix Acqua Implant, Article Number: 140.985
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Z-1863-2025 · View FDA record ↗ - Nobel BiocareOpen, ClassifiedFeb 5, 2025
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
Z-1101-2025 · View FDA record ↗ - SIN SISTEMA DE IMPLANTE NACIONAL S.AOpen, ClassifiedJan 15, 2025
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.
Z-0920-2025 · View FDA record ↗ - Hiossen Inc.Open, ClassifiedMay 18, 2023
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant
Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm
Z-1604-2023 · View FDA record ↗ - Nobel BiocareOpen, ClassifiedAug 23, 2022
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Z-1565-2022 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedMay 4, 2020
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI
The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).
Z-1851-2020 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for
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-1302-2020 · View FDA record ↗
Registered firms
2,269 firms currently registered for this product code
Osseofuse International Inc.
Las Vegas, NV, US
Elos Medtech Timmersdala Ab
TIMMERSDALA Vastra Gotaland, SE
Dentsply Implants Manufacturing Gmbh
Hanau Hesse, DE
Diamodent
Dana Point, CA, US
Nobel Biocare Distribution Center Bv
Venlo Limburg, NL
Sterigenics U.s., Llc
Corona, CA, US
Superior Machined Products, Inc.
Oceanside, CA, US
Trate Llc
Tamarac, FL, US
Greiner Mediscan Gmbh
KREMSMUNSTER Oberosterreich, AT
Sterigenics Us Llc
Gurnee, IL, US
Precision One Medical
Hoover, AL, US
Straumann Manufacturing, Inc.
Mansfield, TX, US
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Thommen Medical, Ag
GRENCHEN Solothurn, CH
Anthogyr
SALLANCHES Haute-Savoie, FR
Dot America, Inc.
Columbia City, IN, US
Straumann Manufacturing, Inc.
Andover, MA, US
Straumann Villeret Sa
Corgemont Bern, CH
Dental Crafters
Marshfield, WI, US
Zest Anchors, Llc
Escondido, CA, US
Aragogamma, S.l.
Les Franqueses del Valles Barcelona, ES
510(k) clearances
1,547 clearances for this product code
- Uniqa Dental, Ltd.Jun 25, 2026
K251188 · UNIQA® Dental Implants System
- Megagen Implant Co., Ltd.Jun 18, 2026
K251232 · MegaGen Zygoma Dental Implant System
- A.B. Dental Devices , Ltd.Jun 18, 2026
K250806 · Dental Implant System
- Inosys, Inc.Jun 17, 2026
K260006 · INOSS System
- Promimic ABMay 12, 2026
K252731 · Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
- Adin Dental Implant Systems , Ltd.Mar 23, 2026
K252031 · Adin Long Dental Implant System
- Izenimplant Co., Ltd.Mar 16, 2026
K253334 · ZENEX Implant System_Short (R-System)
- Institut Straumann AGMar 10, 2026
K252168 · Straumann® BLC Implants - Indication Widening