Drill, Bone, Powered
Dental · 21 CFR 872.4120
Recent MDR events
1,051 adverse event reports on file
- 03.503.286Jul 30, 2026MalfunctionSynthes Gmbh8030965-2026-07841
- MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/90MM FOR 03.503.044Jul 30, 2026MalfunctionSynthes Gmbh8030965-2026-07842
- MATRIXMAND 1.5 DB J-LATCH W/12MM STOP/50Jul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07646
- DRILL BITJul 14, 2026MalfunctionSynthes Gmbh8030965-2026-07102
- 1.8MM DRILL BIT/QC/125MMJul 14, 2026MalfunctionSynthes Gmbh8030965-2026-07119
- 1.8MM DRILL BIT/QC/100MMJul 14, 2026MalfunctionSynthes Gmbh8030965-2026-07127
- DRILL BIT Ø1.1 W/STOP L44.5/8Jul 14, 2026MalfunctionSynthes Gmbh8030965-2026-07129
- DRILL BIT Ø1.1 W/STOP L44.5/6Jul 14, 2026MalfunctionSynthes Gmbh8030965-2026-07128
- MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/8MM STOP/50MMJul 13, 2026MalfunctionSynthes Gmbh8030965-2026-07079
- 1.8MM DRILL BIT/QC/100MMJun 23, 2026MalfunctionSynthes Gmbh8030965-2026-06469
Event type breakdown
Recalls
20 recall events for this product code
- Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for th
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-1304-2020 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the speci
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-1305-2020 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the
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-1306-2020 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for t
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-1307-2020 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the
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-1308-2020 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for t
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-1309-2020 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the
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-1310-2020 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placem
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-1311-2020 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant plac
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-1312-2020 · View FDA record ↗ - Nobel Biocare Usa LlcTerminatedFeb 19, 2020
Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placem
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-1313-2020 · View FDA record ↗
Registered firms
142 firms currently registered for this product code
Synthes Gmbh
Selzach Solothurn, CH
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Synthes Gmbh
Zuchwil Solothurn, CH
Stryker Puerto Rico, Llc.
ARROYO, PR, US
Institut Straumann Ag
BASEL Basel-Stadt, CH
Rose Gmbh Fuer Medizintechnik
Trier Rhineland-Palatinate, DE
W&h Dentalwerk Buermoos Gmbh
BUERMOOS Salzburg, AT
Oketz Logistics Llc
Coral Gables, FL, US
W&h Dentalwerk Buermoos Gmbh - Site 2
BUERMOOS Salzburg, AT
The Anspach Effort, Inc.
Palm Bch Gdns, FL, US
Steris Schweiz Ag
Daniken Solothurn, CH
Exel Inc. Dba Dhl Supply Chain (usa)
Mooresville, IN, US
Somi Medical Gmbh
Pforzheim Baden-Wurttemberg, DE
Jmu Dental, Inc
Fullerton, CA, US
Implant Direct Sybron Manufacturing Llc
Thousand Oaks, CA, US
Goldendent
Roseville, MI, US
Dmetec Co., Ltd
Bucheon Gyeonggi, KR
Nouvag Ag
GOLDACH Sankt Gallen, CH
Synergy Health Ede Bv
Ede Gelderland, NL
E.m.s. Electro Medical Systems S.a.
NYON Vaud, CH
Biolase Mg Llc
Corona, CA, US
510(k) clearances
50 clearances for this product code
- W&H Dentalwerk Bürmoos GmbHJul 31, 2026
K253655 · Angled Screwdriver MED (M-SD090)
- W&H Dentalwerk Buermoos GmbHJun 18, 2026
K253776 · Implantmed Plus II & Piezomed Plus II Module
- Nakanishi, Inc.Dec 23, 2025
K254163 · VarioSurg 4
- Mectron S.P.A.Aug 19, 2024
K242432 · MT-Bone
- Guangdong Jinme Medical Technology Co., Ltd.Jul 18, 2024
K240340 · Surgical Drive System (Model: ES70, ES90, E8)
- Implant Direct Sybron Manufacturing, LLCAug 16, 2023
K231087 · Guided Surgery Kit
- Saeshin Precision Co., Ltd.Jul 13, 2020
K192561 · TRAUS SUS20
- Implant Direct Sybron Manufacturing, LLCJun 30, 2020
K200265 · Surgical Drills