Instrument, Cutting, Orthopedic
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
1,496 adverse event reports on file
- GLOBAL ICONJul 31, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-13078
- ATTUNE NOTCH GUIDE SZ 3Jul 27, 2026MalfunctionDepuy Ireland - 96166711818910-2026-12721
- SIGMA LCSJul 17, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12202
- 2.0/2.4/2.7 PLATE CUTTERJul 16, 2026MalfunctionSynthes Gmbh8030965-2026-07261
- INTUITIONJul 16, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-12131
- SIGMA LCSJul 13, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-11832
- ATTUNEJul 1, 2026MalfunctionDepuy Ireland - 96166711818910-2026-11233
- 2.0/2.4/2.7 PLATE CUTTERJun 30, 2026MalfunctionSynthes Gmbh8030965-2026-06734
- MATRIXMANDIBLEJun 18, 2026MalfunctionSynthes Gmbh8030965-2026-06332
- ATTUNEJun 18, 2026MalfunctionDepuy Ireland - 96166711818910-2026-10438
Event type breakdown
Recalls
27 recall events for this product code
- DePuy Orthopaedics, Inc.TerminatedFeb 13, 2020
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115.
The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
Z-1169-2020 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedAug 5, 2015
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
Saw head separated from the drive unit or began to come loose.
Z-2345-2015 · View FDA record ↗ - Synthes, Inc.TerminatedJun 11, 2014
Synthes Matrix Mandible Short Cut Plate Cutter
It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.
Z-1781-2014 · View FDA record ↗ - Tornier, IncTerminatedSep 13, 2013
AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and th
Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R
Z-2199-2013 · View FDA record ↗ - Biomet, Inc.TerminatedJan 13, 2009
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 55 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485150. A manual surgical instrument fo
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
Z-0873-2009 · View FDA record ↗ - Biomet, Inc.TerminatedJan 13, 2009
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485151. A manual surgical instrument
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
Z-0874-2009 · View FDA record ↗ - Biomet, Inc.TerminatedJan 13, 2009
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 60 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485152. A manual surgical instrument fo
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
Z-0875-2009 · View FDA record ↗ - Biomet, Inc.TerminatedJan 13, 2009
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 62.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485153. A manual surgical instrument
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
Z-0876-2009 · View FDA record ↗ - Biomet, Inc.TerminatedJan 13, 2009
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485154. A manual surgical instrument fo
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
Z-0877-2009 · View FDA record ↗ - Biomet, Inc.TerminatedJan 13, 2009
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 67.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485155. A manual surgical instrument
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
Z-0878-2009 · View FDA record ↗
Registered firms
231 firms currently registered for this product code
Medical Component Specialists
Bellingham, MA, US
Guangzhou Aquila Precise Tools Limited
Guangzhou City Guangdong, CN
Hexamed Pvt Ltd
Sialkot Punjab, PK
Medline Industries, Lp - Northfield
Northfield, IL, US
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
Vehu Medical Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
M.j. Instruments Company (pvt) Ltd.
SIALKOT Punjab, PK
Orthalign, Inc.
Irvine, CA, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Straits Orthopaedics (mfg) Sdn Bhd
Simpang Ampat Pulau Pinang, MY
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Max Hauser Suddeutsche Chirurgiemechanik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Depuy Orthopaedics, Inc.
RAYNHAM, MA, US
Hive International Pvt Ltd.
Sialkot Punjab, PK
Peter Hoehnle Gmbh & Co. Kg
FRITTLINGEN Baden-Wurttemberg, DE
Alto Development Corp.
FARMINGDALE, NJ, US
Paragon 28
Englewood, CO, US
Allied Technologies
Wilsonville, OR, US
Rsb Spine Llc.
Wooster, OH, US
Surgipros Llc
Palmetto, FL, US
Br Surgical Llc
Jacksonville, FL, US
Depuy (ireland)
CO. CORK Munster, IE
Teleflex Llc (nadc)
Olive Branch, MS, US
Depuy Ireland Uc
Co. Cork Munster, IE
Arthrex Gmbh
Munich Bavaria, DE
510(k) clearances
21 clearances for this product code
- Synvasive Technology, Inc.Apr 15, 1994
K933933 · CEBOPLANE
- Synvasive Technology, Inc.Jan 7, 1994
K931737 · HEDLEYL INTRAMEDULLARY PREPARATION BRUSH
- Bowen & Company, Inc.Mar 23, 1987
K870882 · 45 DEGREE SHAVER
- Pilling Co.Sep 24, 1985
K853678 · KAMBIN SPINAL INSTRUMENT SET
- Concept, Inc.Mar 14, 1985
K850423 · CONCEPT SUCTION SLEEVE
- T. Korossurgical Instruments Corp.Mar 14, 1985
K850527 · ARTHROSCOPY SUCTION BIOPSY PUNCH
- Stainless Mfg., Inc.Aug 15, 1984
K841980 · SIDE CUTTING SERRATED BLADE
- Codman & Shurtleff, Inc.Jul 27, 1984
K842774 · CODMAN SUCTION PUNCH-PRODUCT CODES