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)
Top companies in LXH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2008 | Zimmer 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 |
LXH | None listed |
| Sep 17, 2008 | Wright 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 |
LXH | None listed |
| Sep 17, 2008 | Wright 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 |
LXH | None listed |
| Sep 17, 2008 | Wright 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 |
LXH | None listed |
| Sep 17, 2008 | Wright 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 |
LXH | None listed |
| Sep 16, 2008 | Stryker 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 |
LXH | None listed |
| Sep 11, 2008 | Zimmer 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 |
LXH | None listed |
| Sep 11, 2008 | Biomet, Inc. Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter, Part number: 31-555610. Terminated |
LXH | None listed |
| Aug 20, 2008 | Biomet, Inc. Biomet Microplasty Cup Impactor, 1/4" -28 Thread Insert; Model 31-400605. Instrument for hip prosthesis acetabular cup component. Terminated |
LXH | None listed |
| Aug 20, 2008 | Biomet, Inc. Biomet brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component. Terminated |
LXH | None listed |
| Aug 20, 2008 | Biomet, 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 |
LXH | None listed |
| Aug 19, 2008 | Stryker Spine Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery. Terminated |
LXH | None listed |
| Aug 19, 2008 | Stryker Spine Radius Rod Persuader is a non-sterile instrument for use with other devices in spinal surgery. Terminated |
LXH | None listed |
| Aug 17, 2008 | Stryker Howmedica Osteonics Corp. Omnifit EON Surgical Protocol;
Literature Number: LSP48 4/04
Stryker Howmedica Osteonics Corp., Mahwah, NJ Terminated |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Jul 26, 2008 | Stryker 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 |
LXH | None listed |
| Feb 5, 2008 | Biomet, Inc. Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN. Terminated |
LXH | None listed |
| Feb 5, 2008 | Biomet, Inc. Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Biomet Orthopedics, Inc., Warsaw, IN. Terminated |
LXH | None listed |
| Feb 5, 2008 | Biomet, Inc. Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623, Biomet Orthopedics, Inc., Warsaw, IN. Terminated |
LXH | None listed |
| Feb 5, 2008 | Biomet, Inc. Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet Orthopedics, Inc., Warsaw, IN. Terminated |
LXH | None listed |
| Feb 5, 2008 | Biomet, Inc. Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF 31-400621,Biomet Orthopedics, Inc., Warsaw, IN. Terminated |
LXH | None listed |
| Feb 5, 2008 | Biomet, Inc. Biomet RINGLOC + Instrumentation Impactor Plate, Size 20; REF/Part #: 31-400620, Biomet Orthopedics, Inc., Warsaw, IN. Terminated |
LXH | None listed |
| Jan 23, 2008 | Biomet, 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 |
LXH | None listed |
| Dec 22, 2007 | Medtronic 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 |
LXH | None listed |
| Dec 22, 2007 | Medtronic 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 |
LXH | None listed |
| Dec 22, 2007 | Biomet, Inc. Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN Terminated |
LXH | None listed |
| Dec 22, 2007 | Biomet, Inc. Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN Terminated |
LXH | None listed |
| Dec 15, 2007 | Zimmer 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 |
LXH | None listed |
| Dec 15, 2007 | Zimmer 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 |
LXH | None listed |
| Oct 25, 2007 | Smith & Nephew Inc Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component. Terminated |
LXH | None listed |
| Oct 25, 2007 | Smith & Nephew Inc Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant component. Terminated |
LXH | None listed |
| Oct 25, 2007 | Smith & Nephew Inc Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. Hip implant component. Terminated |
LXH | None listed |
| Oct 25, 2007 | Smith & Nephew Inc Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component. Terminated |
LXH | None listed |
| Oct 25, 2007 | Smith & Nephew Inc Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component. Terminated |
LXH | None listed |
| Oct 25, 2007 | Smith & Nephew Inc Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component. Terminated |
LXH | None listed |
| Oct 25, 2007 | Smith & Nephew Inc Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component. Terminated |
LXH | None listed |
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