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Panels › Orthopedic › Product code LXH · Class 1

Orthopedic Manual Surgical Instrument

Regulation 888.4540

0510(k)s in 12 months (58 all time)
8recalls in 12 months (526 all time)
20recalls that name a 510(k)
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Top companies in LXH

DateFirm and productCodeLinked 510(k)
Aug 2, 2010Stryker Howmedica Osteonics Corp.
Howmedica Osteonics Corp., Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide; Catalog Number 7650-5003.
Terminated
LXHNone listed
Aug 2, 2010Stryker Howmedica Osteonics Corp.
X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013; Stryker Howmedica Osteonics Corp Scor
Terminated
LXHNone listed
Aug 2, 2010Stryker Howmedica Osteonics Corp.
Howmedica Osteonics Corp, Stryker Orthopaedics Passport A.R. Knee Instrumentation Distal Guide Stand; Catalog number 7650-5005.
Terminated
LXHNone listed
Jun 24, 2010Smith & Nephew Inc
GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA Drill guide used as manual surgical instrument during knee replacement surge
Terminated
LXHNone listed
Jun 16, 2010Synthes USA (HQ), Inc.
Synthes Medullary Tubes
Terminated
LXHNone listed
Jun 7, 2010Wright Medical Technology Inc
RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsman 11, 1186 Amstelveen, The Netherlands, Wright Medical Technology, 4677 Airline Road, Arlington, TN
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XXL; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XL; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block LG; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block ML; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block MED; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block SM; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XS; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 13; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 11; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 9; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 8; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 7; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 6; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 5; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 4; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile
Terminated
LXHNone listed
May 10, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 3; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile
Terminated
LXHNone listed
Apr 15, 2010Orthohelix Surgical Designs Inc
Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH The intended use: Used to stabilize and aid in the fixation
Terminated
LXHNone listed
Mar 23, 2010Stryker Craniomaxillofacial Division
Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI. The TOM bone mill is designed to grind any type of cortical or cancellous bone.
Terminated
LXHNone listed
Feb 16, 2010Stryker Spine
Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, N
Terminated
LXHNone listed
Feb 16, 2010Stryker Spine
Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, N
Terminated
LXHNone listed
Feb 16, 2010Stryker Spine
Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, N
Terminated
LXHNone listed
Jan 15, 2010Biomet, Inc.
Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery;
Terminated
LXHNone listed
Jan 12, 2010Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek Extended Length Trocar, Size : L=50MM, Item No.: 7578014, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY" Percutaneous Peek Spinal Sys
Terminated
LXHNone listed
Jan 12, 2010Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY" Percutaneous Peek Spinal System
Terminated
LXHNone listed
Nov 10, 2009Biomet Microfixation, Inc.
Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows: REF: 01-0264, QTY,UOM 00001, BYRD SCREW, 2 OX6MM SELF-DRILLING, 12CM, (4-3/4) (L), STAINLESS STEEL, LOT 99999
Terminated
LXHNone listed
Aug 26, 2009Stryker Howmedica Osteonics Corp.
Triathlon MIS 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-5-701, 6541-5-702, 6541-5-703, 6541-5-704, 6541-5-705, 6541-5-706, 6541-5-707, & 6541-5-708; Triathlon MIS Instruments; Non Sterile:
Terminated
LXHNone listed
Aug 26, 2009Stryker Howmedica Osteonics Corp.
Triathlon AR 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, & 6541-0-708; Triathlon MIS Instruments; Non Sterile St
Terminated
LXHNone listed
Aug 4, 2009Smith & Nephew Inc
IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.
Terminated
LXHNone listed
Jun 1, 2009Biomet, Inc.
Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in primary hip arthroplasty.
Terminated
LXHNone listed
Jun 1, 2009Biomet, Inc.
Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in primary hip arthroplasty.
Terminated
LXHNone listed
Apr 28, 2009Wright Medical Technology Inc
Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlingto
Terminated
LXHNone listed
Feb 27, 2009Zimmer Inc.
Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02. The offset rasp handle is a surgical instrument used with various sizes o
Terminated
LXHNone listed
Feb 27, 2009Zimmer Inc.
Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-01. The offset rasp handle is a surgical instrument used with various sizes of
Terminated
LXHNone listed
Jan 23, 2009Integra LifeSciences Corp.
Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only Catalog number R6357A (12 mm), Catalog number R6397A (16 mm), Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro,
Terminated
LXHNone listed
Jan 7, 2009Biomet, Inc.
Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedics, Inc., Warsaw, IN; REF CP461038. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surge
Terminated
LXHNone listed
Jan 7, 2009Biomet, Inc.
Compress Short Instruments Anchor Plug Holder, 12mm, stainless steel, non-sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF CP460193. Non-powered, hand-held device intended for medical purposes for
Terminated
LXHNone listed
Jan 7, 2009Biomet, Inc.
Compress/Finn Instrument Set Compress Anchor Plug Assembly, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF RD425032. Non-powered, hand-held device intended for medical purposes for use wi
Terminated
LXHNone listed
Jan 7, 2009Biomet, Inc.
Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481091. Non-powered, hand-held device intended for medical purposes for use with other
Terminated
LXHNone listed
Jan 7, 2009Biomet, Inc.
Compress Instrument Anchor Plug Holder, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481006. Non-powered, hand-held device intended for medical purposes for use with other devices in
Terminated
LXHNone listed
Oct 28, 2008Stryker Howmedica Osteonics Corp.
Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile; Stryker Trauma GmbH, 2432 Schonkirchen, Germany. Distributed in the US by Howmedica Osteonics Corp., 325 Corporate Driv
Terminated
LXHNone listed
Oct 24, 2008Biomet, Inc.
Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic
Terminated
LXHNone listed
Sep 20, 2008Stryker Howmedica Osteonics Corp.
X-Celerate Universal Block Pegless Size #3, Non Sterile;
Terminated
LXHNone listed
Sep 20, 2008Stryker Howmedica Osteonics Corp.
Universal Notch Preparation Guide, Size #3; Non Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430; authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan;
Terminated
LXHNone listed
Sep 18, 2008Kyphon Inc
KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device i
Terminated
LXHNone listed

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