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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)
Sep 17, 2008Zimmer Inc.
Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.
Terminated
LXHNone listed
Sep 17, 2008Wright Medical Technology Inc
Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Orthopaedic instrument used for the prepar
Terminated
LXHNone listed
Sep 17, 2008Wright Medical Technology Inc
Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Orthopaedic instrument used for the prepar
Terminated
LXHNone listed
Sep 17, 2008Wright Medical Technology Inc
Dynasty Trial Shell 64mm OD, Group H, REF 3300-GH64, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Orthopaedic instrument used for the prepar
Terminated
LXHNone listed
Sep 17, 2008Wright Medical Technology Inc
Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Orthopaedic instrument used for the preparatio
Terminated
LXHNone listed
Sep 16, 2008Stryker Howmedica Osteonics Corp.
Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon Total Knee Instrumentation system. It interfaces with the Modular Handled and the Femoral Stylus to facilitate siz
Terminated
LXHNone listed
Sep 11, 2008Zimmer Inc.
Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a surgical instrument used during knee arthroplasty procedures to snap or lock the polyethylen
Terminated
LXHNone listed
Sep 11, 2008Biomet, Inc.
Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter, Part number: 31-555610.
Terminated
LXHNone listed
Aug 20, 2008Biomet, Inc.
Biomet Microplasty Cup Impactor, 1/4" -28 Thread Insert; Model 31-400605. Instrument for hip prosthesis acetabular cup component.
Terminated
LXHNone listed
Aug 20, 2008Biomet, Inc.
Biomet brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component.
Terminated
LXHNone listed
Aug 20, 2008Biomet, Inc.
Biomet brand Modular Microplasty Cup Inserter, 3/8" thread; Model 31-400600 assembled with a 3/8" threaded insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component.
Terminated
LXHNone listed
Aug 19, 2008Stryker Spine
Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery.
Terminated
LXHNone listed
Aug 19, 2008Stryker Spine
Radius Rod Persuader is a non-sterile instrument for use with other devices in spinal surgery.
Terminated
LXHNone listed
Aug 17, 2008Stryker Howmedica Osteonics Corp.
Omnifit EON Surgical Protocol; Literature Number: LSP48 4/04 Stryker Howmedica Osteonics Corp., Mahwah, NJ
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 8 Right Non-Sterile Catalog Number: 5512-T-802 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 8 Left Non-Sterile Catalog Number: 5512-T-801 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 7 Right Non-Sterile Catalog Number: 5512-T-702 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 7 Left Non-Sterile Catalog Number: 5512-T-701 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 6 Right Non-Sterile Catalog Number: 5512-T-602 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 6 Left Non-Sterile Catalog Number: 5512-T-601 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 5 Right Non-Sterile Catalog Number: 5512-T-502 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 5 Left Non-Sterile Catalog Number: 5512-T-501 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 4 Right Non-Sterile Catalog Number: 5512-T-402 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 4 Left Non-Sterile Catalog Number: 5512-T-401 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial Size 3 Right Non-Sterile Catalog Number : 5512-T-302 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 3 Left Non-Sterile Catalog Number: 5512-T-301 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 2 Right Non-Sterile Catalog Number: 5512-T-202 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 2 Left Non-Sterile Catalog Number 5512-T-201 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use i
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 1 Right Non-Sterile Catalog number: 5512-T-102 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use
Terminated
LXHNone listed
Jul 26, 2008Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 1 Left Non-Sterile Catalog number 5512-T-101 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use i
Terminated
LXHNone listed
Feb 5, 2008Biomet, Inc.
Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN.
Terminated
LXHNone listed
Feb 5, 2008Biomet, Inc.
Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Biomet Orthopedics, Inc., Warsaw, IN.
Terminated
LXHNone listed
Feb 5, 2008Biomet, Inc.
Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623, Biomet Orthopedics, Inc., Warsaw, IN.
Terminated
LXHNone listed
Feb 5, 2008Biomet, Inc.
Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet Orthopedics, Inc., Warsaw, IN.
Terminated
LXHNone listed
Feb 5, 2008Biomet, Inc.
Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF 31-400621,Biomet Orthopedics, Inc., Warsaw, IN.
Terminated
LXHNone listed
Feb 5, 2008Biomet, Inc.
Biomet RINGLOC + Instrumentation Impactor Plate, Size 20; REF/Part #: 31-400620, Biomet Orthopedics, Inc., Warsaw, IN.
Terminated
LXHNone listed
Jan 23, 2008Biomet, Inc.
Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regener
Terminated
LXHNone listed
Dec 22, 2007Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek, 8 mm Trial, size 8 mm, Material Stainless Steel/Radel, quantity 1 each, Non-sterile, Rx only, REF 8004208, Manufactured at: Bartlett, Tennessee, USA
Terminated
LXHNone listed
Dec 22, 2007Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek, 8 mm Curette, size 8 mm, Material Stainless Steel/Radel, quantity 1 each, Non-sterile, Rx only, REF 8003008, Manufactured at: Bartlett, Tennessee, USA
Terminated
LXHNone listed
Dec 22, 2007Biomet, Inc.
Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN
Terminated
LXHNone listed
Dec 22, 2007Biomet, Inc.
Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN
Terminated
LXHNone listed
Dec 15, 2007Zimmer Inc.
Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK
Terminated
LXHNone listed
Dec 15, 2007Zimmer Inc.
Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK
Terminated
LXHNone listed
Oct 25, 2007Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component.
Terminated
LXHNone listed
Oct 25, 2007Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant component.
Terminated
LXHNone listed
Oct 25, 2007Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. Hip implant component.
Terminated
LXHNone listed
Oct 25, 2007Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component.
Terminated
LXHNone listed
Oct 25, 2007Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component.
Terminated
LXHNone listed
Oct 25, 2007Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component.
Terminated
LXHNone listed
Oct 25, 2007Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component.
Terminated
LXHNone listed

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