Bit, Drill
Orthopedic · 21 CFR 888.4540
Recent MDR events
17,754 adverse event reports on file
- flexible drill shaft icJul 31, 2026MalfunctionImplantcast Gmbh3012523063-2026-00057
- Unkn Internal Fixator InstrJul 31, 2026InjurySmith & Nephew, Inc.1020279-2026-01025
- LCP Drill Bit ø2.8 w/Stop L165 2flute f/Jul 31, 2026MalfunctionSynthes Gmbh8030965-2026-07874
- MODULAR FLEXDRILL BITJul 31, 2026MalfunctionZimmer Biomet, Inc.0001822565-2026-02741
- MODULAR FLEX DRILL BITJul 31, 2026MalfunctionZimmer Biomet, Inc.0001822565-2026-02742
- Disposable Kit, Knee FiberTaksJul 30, 2026MalfunctionArthrex, Inc.1220246-2026-04108
- 2.0MM DRILL BIT, (AO), REUSABLEJul 30, 2026MalfunctionArthrex, Inc.1220246-2026-04110
- LCSJul 30, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-13006
- 2.8MM DRILL BIT/QC/165MMJul 30, 2026MalfunctionSynthes Gmbh8030965-2026-07859
- GRYPHONJul 30, 2026MalfunctionDepuy Mitek Llc Us1221934-2026-03384
Event type breakdown
Recalls
114 recall events for this product code
- Waldemar Link GmbH & Co. KG (Mfg Site)Open, ClassifiedMar 27, 2026
Embrace Drill Tower, Wedged (25mm);
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
Z-1651-2026 · View FDA record ↗ - Waldemar Link GmbH & Co. KG (Mfg Site)Open, ClassifiedMar 27, 2026
Embrace Drill Tower, Standard/Lateral (25mm);
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
Z-1652-2026 · View FDA record ↗ - Waldemar Link GmbH & Co. KG (Mfg Site)Open, ClassifiedMar 6, 2024
Embrace Drill Tower, Wedged (25mm)
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
Z-1257-2024 · View FDA record ↗ - Waldemar Link GmbH & Co. KG (Mfg Site)Open, ClassifiedMar 6, 2024
Embrace Drill Tower, Standard/Lateral (25mm)
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
Z-1258-2024 · View FDA record ↗ - Biomet, Inc.TerminatedDec 17, 2020
RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215,
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Z-0631-2021 · View FDA record ↗ - Biomet, Inc.TerminatedMay 26, 2016
Various trauma and sports medicine instruments and implants.
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
Z-1821-2016 · View FDA record ↗ - Synthes (USA) Products LLCTerminatedMay 23, 2016
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S
The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.
Z-1709-2016 · View FDA record ↗ - Synthes (USA) Products LLCTerminatedMay 23, 2016
3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile
The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.
Z-1710-2016 · View FDA record ↗ - Trilliant Surgical Ltd.TerminatedAug 24, 2015
3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System
The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
Z-2452-2015 · View FDA record ↗ - Synthes, Inc.TerminatedJun 4, 2015
3.2 mm Cannulated Drill Bit/ QC 170 mm
affected parts and lots of the Cannulated Drill Bits have the potential to break during use
Z-1711-2015 · View FDA record ↗
Registered firms
573 firms currently registered for this product code
Acumed Llc
Hillsboro, OR, US
Si-bone, Inc.
Santa Clara, CA, US
Platts And Nisbett Ltd.
Sheffield, GB
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Medline Renewal
Redmond, OR, US
Science & Bio Materials, S.b.m. Sas
LOURDES Hautes-Pyrenees, FR
Wishbone Medical Inc.
Larwill, IN, US
Biocells Discoveries Internacional (biocells)
Quito Pichincha, EC
Merit Medical Systems, Inc.
South Jordan, UT, US
Arthrex Colombia Sas
Bogota Cundinamarca, CO
Farmaco Quimica Nacional, S.a.
La Esperilla Santo Domingo, DO
Engineered Medical Systems, Llc
Bartlett, TN, US
Memry Corporation
Bethel, CT, US
Precision Edge Surgical Products Company
Sault Sainte Marie, MI, US
Millennium Surgical Corp
Schaumburg, IL, US
Rudolf Storz Gmbh
EMMINGEN Baden-Wurttemberg, DE
Norwood Medical Llc
Dayton, OH, US
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Omega Surgical Instruments, Inc.
Flint, MI, US
Synergy Health Ast, Srl
Alajuela, CR
Glw, Inc.
Englewood Cliffs, NJ, US
Ldr Medical
Sainte-Savine Aube, FR
Eagle Medical Packaging Sterilization, Inc.
PASO ROBLES, CA, US
Viant Medical, Llc
Fort Wayne, IN, US
Medartis Ag
BASEL Basel-Stadt, CH
510(k) clearances
11 clearances for this product code
- Renovo Life, LLCJan 15, 2016
K151661 · Renovo Life Hard Carbon Coated Drill Bit
- Hand Biomechanics Lab, Inc.Dec 22, 1994
K942906 · AGEE-WRISTJACK PRE-DRILL KIT
- Neoligaments, Ltd.Aug 6, 1993
K930339 · REAMER BIT
- W. L. Gore & Associates, Inc.Jan 16, 1992
K915692 · CANNULATED DRILL BIT
- Mitek Surgical Products, Inc.Oct 6, 1989
K892903 · MITEK ANCHOR DRILL
- Kenneth J. Hoek, M.D., Inc.Feb 6, 1987
K870217 · FEMORAL CEMENT REMOVAL INSTRUMENTS
- Bowen & Company, Inc.Sep 5, 1986
K863147 · GLENOID DRILL
- Plastafil, Inc.Aug 27, 1984
K841629 · DRILL BIT