Bit, Surgical
General, Plastic Surgery · 21 CFR 878.4820
Recent MDR events
683 adverse event reports on file
- PERFORM REVERSED PERIPHERAL and SPHERE SCREWDRIVER BIT T20Jul 29, 2026MalfunctionTornier Inc0001649390-2026-00775
- PERFORM REVERSED PERIPHERAL and SPHERE SCREWDRIVER BIT T20Jul 27, 2026MalfunctionTornier Inc0001649390-2026-00760
- PERFORM REVERSED PERIPHERAL and SPHERE SCREWDRIVER BIT T20Jul 27, 2026MalfunctionTornier Inc0001649390-2026-00761
- 2.0MM DRILL BIT W/DEPTH MARK QC/110MMJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07754
- 4.2mm Radiolucent Drill BitJul 22, 2026MalfunctionStryker Instruments-a Division Of Stryker Corp3015967359-2026-99403
- RETROGRADE DRL 8.5MMJul 18, 2026MalfunctionSmith & Nephew, Inc.1219602-2026-02259
- PERFORM REVERSED PERIPHERAL AND SPHERE SCREWDRIVER BIT T20Jul 15, 2026MalfunctionTornier Inc0001649390-2026-00722
- PERFORM REVERSED PERIPHERAL AND SPHERE SCREWDRIVER BIT T20Jul 9, 2026MalfunctionTornier Inc0001649390-2026-00706
- PERFORM REVERSED PERIPHERAL AND SPHERE SCREWDRIVER BIT T20Jul 9, 2026MalfunctionTornier Inc0001649390-2026-00707
- PERFORM REVERSED PERIPHERAL AND SPHERE SCREWDRIVER BIT T20Jul 9, 2026MalfunctionTornier Inc0001649390-2026-00709
Event type breakdown
Recalls
17 recall events for this product code
- Synthes, Inc.TerminatedMay 29, 2014
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Fla
Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.
Z-1669-2014 · View FDA record ↗ - Biomet, Inc.TerminatedDec 28, 2005
Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585.
The bit may bend or fracture during use.
Z-0329-06 · View FDA record ↗ - Zimmer Inc.TerminatedOct 28, 2005
Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039.
The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique.
Z-0091-06 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Z-1838-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Z-1839-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Z-1840-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Z-1841-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Z-1842-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Z-1843-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedUnknown
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Z-1844-2017 · View FDA record ↗
Registered firms
102 firms currently registered for this product code
Simagec
ROUSSET CEDEX Bouches-du-Rhone, FR
Orthopediatrics, Corp
Warsaw, IN, US
Hexamed Pvt Ltd
Sialkot Punjab, PK
Microport Orthopedics Global Supply Center Limited
Shanghai, CN
Structure Medical, Llc.
Mooresville, NC, US
Sterigenics Us, Llc
Lewis Center, OH, US
Medipost, Inc.
Cambridge, MA, US
Responsive Arthroscopy
Minneapolis, MN, US
Acumed Llc
Hillsboro, OR, US
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Stryker Ireland Ltd., Instruments Division
CARRIGTWOHILL, CO.CORK Munster, IE
Depuy Orthopaedics
BRIDGEWATER, MA, US
Paragon Medical Inc.
Smithfield, UT, US
Sterigenics U.s., Llc
Corona, CA, US
Conmed Corporation
Utica, NY, US
Hipp Medical Ag
Renquishausen Baden-Wurttemberg, DE
Stryker Endoscopy
SAN JOSE, CA, US
Guangzhou Aquila Precise Tools Limited
Guangzhou City Guangdong, CN
Cefimeca
La Talaudiere Loire, FR
Rti Surgical, Inc. (dba Rti Biologics, Inc.)
ALACHUA, FL, US
Avalign Instruments & Implants
FORT WAYNE, IN, US
Selenium Medical S.a.s.
La Rochelle Charente-Maritime, FR
Depuy Mitek, Inc.
RAYNHAM, MA, US
Li Wai Precision International Limited
Tsimshatsui, Kowloon, HK
Tornier Inc.
Columbia City, IN, US
510(k) clearances
3 clearances for this product code