Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
General, Plastic Surgery · 21 CFR 878.4820
Recent MDR events
50,267 adverse event reports on file
- HAND PIECE FOR BATTERY POWERED DRIVERJul 31, 2026MalfunctionSynthes Gmbh8030965-2026-07867
- FLIPCUTTER II, SHORT 10MMJul 31, 2026MalfunctionArthrex, Inc.1220246-2026-04153
- LATITUDE FLEXIBLE REAMER 5MMJul 31, 2026MalfunctionTornier Inc0001649390-2026-00776
- EXPEDIUMJul 31, 2026MalfunctionDepuy Spine Inc1526439-2026-01123
- EXPEDIUMJul 31, 2026MalfunctionDepuy Spine Inc1526439-2026-01133
- EXPEDIUMJul 31, 2026MalfunctionDepuy Spine Inc1526439-2026-01138
- EXPEDIUMJul 31, 2026MalfunctionDepuy Spine Inc1526439-2026-01137
- EXPEDIUMJul 31, 2026MalfunctionDepuy Spine Inc1526439-2026-01135
- EXPEDIUMJul 31, 2026MalfunctionDepuy Spine Inc1526439-2026-01136
- EXPEDIUMJul 31, 2026MalfunctionDepuy Spine Inc1526439-2026-01142
Event type breakdown
Recalls
101 recall events for this product code
- The Anspach Effort, Inc.TerminatedJan 11, 2018
OSCILLATING SAW ATTACHMENT
This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
Z-0398-2018 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedSep 22, 2017
Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Z-3145-2017 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedSep 22, 2017
Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic surgical instrument.
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Z-3146-2017 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedSep 22, 2017
M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile. orthopedic surgical instrument.
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Z-3147-2017 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedSep 22, 2017
ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile. orthopedic surgical instrument.
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Z-3148-2017 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedSep 22, 2017
Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile. orthopedic surgica
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Z-3149-2017 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedSep 22, 2017
ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgical instrument.
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Z-3150-2017 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedSep 22, 2017
Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile. orthopedic surgical instrument.
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Z-3151-2017 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedSep 22, 2017
Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument.
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Z-3152-2017 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedSep 22, 2017
Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile. orthopedic surgical instrument.
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Z-3153-2017 · View FDA record ↗
Registered firms
583 firms currently registered for this product code
Crosmed S.a.
Buenos Aires, AR
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Arthrex Logistic Center Canada
London Ontario, CA
Onyx Medical Llc
MEMPHIS, TN, US
Jiangsu Baide Medical Instrument Co.,ltd.
Zhangjiagang Jiangsu, CN
Baxter Healthcare Of Puerto Rico Llc
AIBONITO, PR, US
Depuy Orthopaedics
BRIDGEWATER, MA, US
Isomedix Operations Inc.
Northborough, MA, US
Jabil Inc.
AUBURN HILLS, MI, US
Axia Orthopedics
Portland, OR, US
Stryker Trauma Gmbh
SCHOENKIRCHEN Schleswig-Holstein, DE
Synthes Gmbh
Selzach Solothurn, CH
Synthes (usa) Products Llc
West Chester, PA, US
Authorized Acquisitions Llc
Mokena, IL, US
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Brasseler U.s.a. Medical, Llc
Savannah, GA, US
Norwood Medical Llc
Dayton, OH, US
Kammerer Medical Systems Gmbh & Co. Kg
Stockach Baden-Wurttemberg, DE
Synthes Gmbh
Zuchwil Solothurn, CH
Arch Medical Solutions - Elmhurst
Elmhurst, IL, US
Lincotek Medical Llc
Vandalia, OH, US
Arthrex California Technology, Incorporated
Santa Barbara, CA, US
Sontec Instruments, Inc.
CENTENNIAL, CO, US
Osteoremedies, Llc
Memphis, TN, US
510(k) clearances
76 clearances for this product code
- Mcginley InnovationsFeb 20, 2015
K143191 · IntelliSense Drill
- Ortho Solutions LimitedJan 20, 2011
K102743 · ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
- The Anspach Effort, Inc.Jan 16, 2007
K063688 · SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
- Zimmer TrabecularMay 26, 2005
K050766 · EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
- Synthes (Usa)Jan 5, 2005
K043310 · SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
- Medical Device ServicesSep 18, 2002
K022744 · REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
- Adven MedicalFeb 4, 2002
K012676 · REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
- Adven MedicalFeb 4, 2002
K012694 · REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS