125 results
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23ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 10, 2018
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·December 7, 2016
Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile. orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·October 4, 2017
Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile. orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·October 4, 2017
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 2024
Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
FDA Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·February 8, 2017
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 14, 2018
3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 1, 2016
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 1, 2016
Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027
FDA Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·October 20, 2021
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
FDA Enforcement
Class II
·Ongoing·Synthes (USA) Products LLC·March 13, 2024
ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile. orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·October 4, 2017
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp.·May 29, 2024
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
FDA Enforcement
Class II
·Terminated·Trilliant Surgical, LLC·January 22, 2020
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·April 7, 2021
Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·October 4, 2017
Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, Nonsterile. orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·October 4, 2017
Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·October 4, 2017
Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035, Nonsterile. orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·October 4, 2017
Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile. orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·October 4, 2017