Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment
General, Plastic Surgery · 21 CFR 878.4820
Recent MDR events
2,859 adverse event reports on file
- INHANCEJul 21, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-12354
- 1.25MM X 150MM SS GUIDE WIRE, THREADEDApr 28, 2026MalfunctionOrthopediatrics3006460162-2026-00023
- CS META AUG REAMER INNER SHAFTMar 4, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-04099
- 1.6MM X 200MM SS GUIDE WIRE, THREADEDMar 2, 2026MalfunctionOrthopediatrics3006460162-2026-00008
- VALKYRIE® - POWER DRIVERJan 29, 2026MalfunctionJeil Medical Corporation3004049923-2026-00001
- VALKYRIE® - POWER DRIVERJan 22, 2026MalfunctionJeil Medical Corporation24143836
- STRYKER SAGITTAL SAWSep 5, 2025MalfunctionSteris Corporation1527821-2025-00018
- STRYKER CORDLESS DRIVERAug 26, 2025InjuryStryker InstrumentsMW5175270
- CS META AUG REAMER HOUSING HWMay 28, 2025MalfunctionDepuy Ireland - 30155162661818910-2025-08603
- CS META AUG REAMER HEADMay 28, 2025MalfunctionDepuy Ireland - 30155162661818910-2025-08605
Event type breakdown
Recalls
10 recall events for this product code
- Stryker Instruments Div. of Stryker CorporationTerminatedMar 10, 2009
Stryker Cordless Driver 3 Handpiece. Stryker Instruments, Kalamazoo, MI; REF 4300.
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Z-1021-2009 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 10, 2009
Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203.
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Z-1022-2009 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 10, 2009
Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203-000-000S1.
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Z-1023-2009 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 10, 2009
Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6205.
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Z-1024-2009 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 10, 2009
Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6205-000-000S1.
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Z-1025-2009 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 10, 2009
Stryker Reciprocating Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6206.
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Z-1026-2009 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 10, 2009
Stryker Sternum Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6207.
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Z-1027-2009 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 10, 2009
Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6208. Note: The product label declares the product to be a handp
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Z-1028-2009 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 10, 2009
Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6208-000-000S4.
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Z-1029-2009 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 10, 2009
Stryker Precision Oscillating Tip Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6209.
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Z-1030-2009 · View FDA record ↗
Registered firms
94 firms currently registered for this product code
Suzhou Number Win Medical Technology Co., Ltd.
Zhangjiagang Jiangsu, CN
Sterigenics Us Llc
Gurnee, IL, US
Straits Orthopaedics (mfg) Sdn Bhd
Perai Pulau Pinang, MY
Boulder Biomed Llc
Boulder, CO, US
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
Shalby Advanced Technologies, Inc.
El Dorado Hills, CA, US
Silony Medical International Ag
Leinfelden Echterdingen Baden-Wurttemberg, DE
Mainstream Medical Devices
Austin, TX, US
Spineology Inc.
Saint Paul, MN, US
Micropulse Inc
Columbia City, IN, US
Paragon Medical Inc.
Castleton, IN, US
Ortho Solutions Uk Limited
Maldon Essex, GB
Depuy Orthopaedics, Inc.
WARSAW, IN, US
Osteomed
ADDISON, TX, US
Innovasis, Inc.
Millcreek, UT, US
Eagle Medical Packaging Sterilization, Inc.
PASO ROBLES, CA, US
Paragon Medical, Inc.
PIERCETON, IN, US
Silony Medical Gmbh
Leinfelden-Echterdingen Baden-Wurttemberg, DE
Zurimed Technologies Ag
Zurich, CH
Vorzeigen
Connersville, IN, US
Huzhou Junda Industry Co., Ltd.
Anji Zhejiang, CN
Mps Micro Precision Systems Ag
Biel-Bienne Bern, CH
Apothecaries Sundries Mfg Pvt Ltd
GURUGRAM Haryana, IN
Microaire Surgical Instruments Llc
CHARLOTTESVILLE, VA, US
Sterigenics Us, Llc
Lewis Center, OH, US
510(k) clearances
29 clearances for this product code
- Jeil Medical CorporationDec 27, 2016
K163308 · SMARTO
- Insurgical, LLCNov 6, 2012
K112599 · INSURGICAL SINGLE USE POWER EQUIPMENT
- Jeil Medical CorporationDec 17, 2010
K101563 · SMARTO
- Stryker InstrumentsSep 4, 1997
K972367 · STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
- Implant Resource, Inc.Apr 30, 1997
K970378 · STRYKER 2115 REPLACEMENT BATTERY (2115)
- Acu Med, Inc.May 7, 1996
K960711 · ACUMED BONE GRAFT SYSTEM
- Strenumed, Inc.May 17, 1995
K951450 · SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY
- S & S Orthopedic , Ltd.Mar 2, 1995
K944488 · S & S ORTHOPEDIC WIRE DRIVER 701