Motor, Surgical Instrument, Pneumatic Powered
General, Plastic Surgery · 21 CFR 878.4820
Recent MDR events
1,030 adverse event reports on file
- WOODPECKER 1:5 HANDPIECEJul 6, 2026MalfunctionUnkMW5190299
- ENDO GRASPJul 1, 2026MalfunctionCovidien2647580-2026-01964
- ENDO DISSECTMay 21, 2026MalfunctionCovidien2647580-2026-01464
- ENDO DISSECTApr 27, 2026MalfunctionCovidien2647580-2026-01196
- ENDO DISSECTApr 20, 2026MalfunctionCovidien2647580-2026-01105
- ENDO DISSECTApr 20, 2026MalfunctionCovidien2647580-2026-01106
- ENDO DISSECTApr 17, 2026MalfunctionCovidien2647580-2026-01084
- ENDO DISSECTApr 17, 2026MalfunctionCovidien2647580-2026-01085
- ENDO DISSECTApr 17, 2026MalfunctionCovidien2647580-2026-01086
- ENDO DISSECTMar 2, 2026MalfunctionCovidien2647580-2026-00572
Event type breakdown
Recalls
54 recall events for this product code
- Pro-Dex IncOpen, ClassifiedApr 14, 2023
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2
Incorrect Unique Device Identifier/GTIN code was used on product.
Z-1391-2023 · View FDA record ↗ - MicroAire Surgical Instruments, LLCTerminatedMay 27, 2016
Pneumatic Impactor, General Surgery, With Microaire Hose Connector
MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.
Z-1834-2016 · View FDA record ↗ - Aesculap, Inc.TerminatedJan 3, 2014
Aesculap Hi-Line XXS handpiece
Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.
Z-0623-2014 · View FDA record ↗ - Linvatec Corp.TerminatedJan 15, 2009
ConMed Linvatec Hall Surgical Blades, Sterile OSC/SAG BLADE, Catalog # U655, U554, and U551.
Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
Z-0360-2009 · View FDA record ↗ - Linvatec Corp.TerminatedJan 15, 2009
ConMed Linvatec Hall Surgical Blades, Sterile FREE HAND SAW BLADE MICRO CHOICE, Catalog # C8804, C8802, and C8806.
Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
Z-0361-2009 · View FDA record ↗ - Linvatec Corp.TerminatedJan 15, 2009
ConMed Linvatec Hall Surgical Blades, Sterile INTEX BLADE, Catalog #
Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
Z-0362-2009 · View FDA record ↗ - Linvatec Corp.TerminatedJan 15, 2009
ConMed Linvatec Hall Surgical Blades, Sterile LG BONE OSC BLADE, Catalog #00507154800, 00507154700, 00507123600, 00507155700, 00507155800, 00507159000, and 00
Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
Z-0363-2009 · View FDA record ↗ - Linvatec Corp.TerminatedJan 15, 2009
ConMed Linvatec Hall Surgical Blades, Sterile MAX DRV OSC BLD, Catalog # 00507318100.
Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
Z-0364-2009 · View FDA record ↗ - Linvatec Corp.TerminatedJan 15, 2009
ConMed Linvatec Hall Surgical Blades, Sterile MICRO SAG SAW BLADE FINE, Catalog # 00502313400, 00502324900, 00505303350, and 00504414500.
Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
Z-0365-2009 · View FDA record ↗ - Linvatec Corp.TerminatedJan 15, 2009
ConMed Linvatec Hall Surgical Blades, Sterile OSC BLADE, Catalog # 00507116100 and 00507158200.
Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
Z-0366-2009 · View FDA record ↗
Registered firms
56 firms currently registered for this product code
Sterigenics U.s., Llc
Atlanta, GA, US
Topmed Medical Devices Inc
Irvine, CA, US
Covidien
North Haven, CT, US
Medtronic Powered Surgical Solutions
FORT WORTH, TX, US
Wenzhou Songling Healthcare Equipment Co., Ltd
Wenzhou Zhejiang, CN
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Carevature Technologies Ltd
Netanya Central, IL
Aesculap, Inc.
HAZELWOOD, MO, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Linvatec Corporation
LARGO, FL, US
De Soutter Medical Ltd.
ASTON CLINTON Buckinghamshire, GB
R.h. Cross Enterprises, Inc.
Portage, MI, US
Imt Integral Medizintechnik Ag
CH-6006, LUZERN, CH
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Sterigenics Us Llc
Charlotte, NC, US
Ningbo Boly Medical Equipment Co.,ltd.
Yuyao Zhejiang, CN
Medacta International Sa
Castel San Pietro Ticino, CH
Shanghai Bojin Electric Instrument & Device Co.,ltd.
Shanghai, CN
Medline Renewal
Redmond, OR, US
Integrated Medical Technologies Usa, Llc
LINO LAKES, MN, US
Shanghai Foreign Trade Enterprises Pudong Co., Ltd.
Shanghai, CN
Wenzhou Ezekiel Creative Electronic Technology Co., Ltd.
Wenzhou Zhejiang, CN
510(k) clearances
23 clearances for this product code
- Aesculap, Inc.Mar 7, 1996
K960473 · AESCULAP POWER SYSTEM HANDPIECE
- Sodem Diffusion SAJan 22, 1996
K955174 · SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY
- Surgical Dynamics, Inc.Oct 30, 1995
K942987 · NUCLEOTOME L KIT
- Midas Rex Pneumatic Tools, Inc.Oct 18, 1995
K954076 · MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS
- Midas Rex Pneumatic Tools, Inc.Sep 15, 1995
K953433 · MIDAS REX TELESCOPING SYSTEM
- Midas Rex Pneumatic Tools, Inc.Sep 14, 1995
K953432 · ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS
- Midas Rex Pneumatic Tools, Inc.Jul 17, 1995
K952463 · GS & GS20 SURGICAL TOOL SYSTEM
- Midas Rex Pneumatic Tools, Inc.May 26, 1995
K952300 · MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS)