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) |
|---|---|---|---|
| Jul 1, 2013 | Zimmer, Inc. Bigliani/Flatow The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30.
Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface. Terminated |
LXH | None listed |
| Jul 1, 2013 | Zimmer, Inc. Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40.
Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface. Terminated |
LXH | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504
- Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511
- ENDO Terminated |
LXH | None listed |
| Jun 15, 2013 | Biomet, Inc. Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems.
Product Usage:
The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractur Terminated |
LXH | None listed |
| Apr 5, 2013 | Synthes USA HQ, Inc. Flexible Grip which is part of the Synthes Universal Nail System.
Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures. Terminated |
LXH | None listed |
| Mar 19, 2013 | DePuy Orthopaedics, Inc. Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques:
Sigma HP Instruments Classic Surgical Technique,0612-89-510
Sigma HP Instruments Balanced Surgical Technique, 0612-88-510
Sigma HP Terminated |
LXH | None listed |
| Mar 18, 2013 | Stryker Howmedica Osteonics Corp. Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE Terminated |
LXH | K053514 |
| Mar 8, 2013 | Biomet, Inc. REF S313152 Straight Acetabular Inserter Handle Ringloc
non-sterile
Orthopedic manual surgical instrument Terminated |
LXH | None listed |
| Mar 8, 2013 | Stryker Howmedica Osteonics Corp. Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100 Terminated |
LXH | None listed |
| Feb 28, 2013 | Stryker Spine Stryker XIA 3 Iliac Screwdriver, 3-PCS.
The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrume Terminated |
LXH | None listed |
| Feb 5, 2013 | Linvatec Corp. dba ConMed Linvatec ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm
Orthopedic manual surgical instrument - Bone Punch Terminated |
LXH | None listed |
| Jan 30, 2013 | Greatbatch Medical 45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031.
Model #:
P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU2600 Terminated |
LXH | None listed |
| Dec 22, 2012 | Stryker Howmedica Osteonics Corp. Stryker Howmedica Osteonics; Stryker T2 Humerus System
Teflon Tube, sterile; REF 1806-0073S
The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applicat Terminated |
LXH | None listed |
| Dec 4, 2012 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics
TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS
REF 6543-2-600;NON-STERILE
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 USA
A Subsidiary of Stryker Cor Terminated |
LXH | None listed |
| Dec 4, 2012 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics
FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS
REF 6543-1-600;NON-STERILE
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 USA
A Subsidiary of Stryker Corp. Terminated |
LXH | None listed |
| Nov 19, 2012 | Stryker Spine SPECIALTY AUDIBLE TORQUE WRENCH, XIA
IS2217XLP
MFG BY: STRYKER SPINE
2 PEARL COURT
ALLENDALE NJ 07401-1677
The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the bl Terminated |
LXH | None listed |
| Nov 19, 2012 | Stryker Spine Stryker MANTIS TORQUE WRENCH
REF 48287028
Manufactured by:
Stryker pine SAS
Z.I MARTICOT-33610-CESTAS-FRANCE
+33 (0)5.57.97.06.30
http://www.stryker.com
Distributed in the USA by:
Stryker Spine,
2 Terminated |
LXH | None listed |
| Nov 19, 2012 | Stryker Spine Stryker XIA 3 TORQUE WRENCH
REF 48237028
Manufactured by:
Stryker pine SAS
Z.I MARTICOT-33610-CESTAS-FRANCE
+33 (0)5.57.97.06.30
http://www.stryker.com
Distributed in the USA by:
Stryker Spine,
2 P Terminated |
LXH | None listed |
| Oct 29, 2012 | Stryker Spine Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm,
Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France
+33 (0) 5.57.97.06.30
http://www.stryker.com
Distributed in the USA by Stryker Spi Terminated |
LXH | None listed |
| Oct 29, 2012 | Linvatec Corp. dba ConMed Linvatec "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***"
To create pathway for insertion of CrossFT Suture Anchor into bone. Terminated |
LXH | None listed |
| Oct 18, 2012 | Aesculap, Inc. Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) Terminated |
LXH | None listed |
| Sep 14, 2012 | Tedan Surgical Innovations Llc Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, Terminated |
LXH | None listed |
| Aug 6, 2012 | Linvatec Corp. dba ConMed Linvatec PopLok Punch labeled in part:
"PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, Terminated |
LXH | None listed |
| Aug 6, 2012 | Linvatec Corp. dba ConMed Linvatec CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone. Terminated |
LXH | None listed |
| Jul 26, 2012 | Stryker Howmedica Osteonics Corp. Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401.
During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower ( Terminated |
LXH | None listed |
| Jul 19, 2012 | Stryker Spine Stryker AVS Navigator Trials 6mm-15mm
Manufactured by:
Stryker Spine SAS
Z.1 Marticot-33610-Cestas -France
+33 (0) 5.57.97.06.30
http;//www.stryker.com
Distributed in the USA by
Stryker Spine
2 Pear Terminated |
LXH | None listed |
| Jun 6, 2012 | Smith & Nephew Inc PERI-LOC(R) TARGETER 2.7 MM PF PIN 40 MM, SST, REF 71173406, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
LXH | None listed |
| Jun 6, 2012 | Smith & Nephew Inc PERI-LOC(R) TARGETER 2.7 MM PF PIN 18 MM, SST, REF 71173438, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
LXH | None listed |
| Jun 6, 2012 | Smith & Nephew Inc 3.2 MM TROCAR, REF 71751136, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
LXH | None listed |
| Jun 6, 2012 | Smith & Nephew Inc 3.2 MM IMHS(R) CP SHORT BRAD POINT DRILL, REF 71687001, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
LXH | None listed |
| Jun 6, 2012 | Smith & Nephew Inc 3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71780105, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
LXH | None listed |
| Jun 6, 2012 | Smith & Nephew Inc 3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71751149, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
LXH | None listed |
| Jun 6, 2012 | Smith & Nephew Inc 3.5 MM X 191 MM DRILL, REF 71173806, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
LXH | None listed |
| Jun 6, 2012 | Smith & Nephew Inc 2.7 MM X 191 MM DRILL, REF 71173804, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
LXH | None listed |
| Jun 6, 2012 | Smith & Nephew Inc 2.0 MM X 191 MM DRILL, REF 71173802, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
LXH | None listed |
| Jun 6, 2012 | Smith & Nephew Inc 4.8 MM X 1.8 MM DRILL FOR HA COATED HALF PINS, CANNULATED, REF 71070845, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
LXH | None listed |
| May 17, 2012 | Stryker Howmedica Osteonics Corp. Tibial Alignment Handle
Triathlon Instruments
CAT #: 6541-2-807
Nav Tibial Alignment Handle Triathlon Instruments
CAT #; 6541-2-808
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
The Terminated |
LXH | None listed |
| Apr 19, 2012 | Medtronic Sofamor Danek USA Inc VERTEX MAX (R) Cannulated, VERTEX MAX (R), and VERTEX (R) Reconstruction System Adjustable Drill Stop, REF 6860460, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis Terminated |
LXH | None listed |
| Apr 19, 2012 | Medtronic Sofamor Danek USA Inc PREMIER(R) Anterior Cervical Plate System Adjustable Drill Stop, REF 6905712, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132
Product Usage:
Manu Terminated |
LXH | None listed |
| Apr 19, 2012 | Medtronic Sofamor Danek USA Inc ATLANTIS(TM) Anterior Cervical Plate System Adjustable Drill Stop, REF 876-460, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132
Product Usage:
Ma Terminated |
LXH | None listed |
| Apr 16, 2012 | DePuy Orthopaedics, Inc. DePuy Attune Impaction Handle Warsaw, IN 46582
Packaging: Product is packed within a polyethylene bag, with protection added as needed for sharp and/or fragile points.
Product Usage: The ATTUNE Impa Terminated |
LXH | None listed |
| Apr 16, 2012 | DePuy Orthopaedics, Inc. PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1 unit)
The PFC Steinman Pin/Drill Pack Sterile is part of the PFC Modular Knee Instrument system. The single pac Terminated |
LXH | None listed |
| Mar 22, 2012 | Stryker Howmedica Osteonics Corp. Osteonics Shoulder Glenoid Spanner
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The Solar Upper Extremity System Hemi and Total Shoulder Arthroplasty system is designed to address Terminated |
LXH | None listed |
| Mar 19, 2012 | Biomet U.K., Ltd. Vanguard Knee Instrumentation Tibial Resection Tower Universal with alignment tower geometry, REF 32487557, LOT 2561334, Biomet UK Ltd, South Wales, UK
Product Usage: Usage: Used to guide a saw b Terminated |
LXH | None listed |
| Mar 19, 2012 | Biomet U.K., Ltd. Vanguard Knee Instrumentation Distal Cutting Block without Handles, REF 32-487002 LOT 2561329, Biomet UK Ltd, South Wales, UK
Used to guide a saw blade in resecting the the distal femor. Intended to Terminated |
LXH | None listed |
| Jan 18, 2012 | Stryker Howmedica Osteonics Corp. Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument
Brand Name: Specialty Straight Command Common Name: Handle Classification Name: Ort Terminated |
LXH | None listed |
| Nov 2, 2011 | Encore Medical, Lp RSP Baseplate Rim Planer (Size 32, 36, 40):
DJO Surgical Instruments and Instrument Cases
DJO surgical
Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758
Contact information: DJO Surgical, ATTN: Terminated |
LXH | None listed |
| Nov 2, 2011 | Encore Medical, Lp RSP Humeral Socket Reamer (Size 32 SML):
DJO Surgical Instruments and Instrument Cases
DJO surgical
Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758
Contact information: DJO Surgical, ATTN: Cu Terminated |
LXH | None listed |
| Sep 30, 2011 | Biomet, Inc. Comprehensive Reverse Humeral Fracture Inserter
REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1.
Instrument that is attached to the trial prosthesis for placement in the prep Terminated |
LXH | K023063 |
| Aug 31, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. Depuy Mitek Ratchet Handle with Quick Connect
Product code: 219970.
Instrument used with anchor inserters for insertion of DePuy Mitek Interference Screws (orthopedic). Terminated |
LXH | None listed |
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