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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)
Jul 1, 2013Zimmer, 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
LXHNone listed
Jul 1, 2013Zimmer, 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
LXHNone listed
Jul 1, 2013Surgical 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
LXHNone listed
Jun 15, 2013Biomet, 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
LXHNone listed
Apr 5, 2013Synthes 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
LXHNone listed
Mar 19, 2013DePuy 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
LXHNone listed
Mar 18, 2013Stryker 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
LXHK053514
Mar 8, 2013Biomet, Inc.
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Terminated
LXHNone listed
Mar 8, 2013Stryker Howmedica Osteonics Corp.
Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Terminated
LXHNone listed
Feb 28, 2013Stryker 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
LXHNone listed
Feb 5, 2013Linvatec Corp. dba ConMed Linvatec
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
Terminated
LXHNone listed
Jan 30, 2013Greatbatch 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
LXHNone listed
Dec 22, 2012Stryker 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
LXHNone listed
Dec 4, 2012Stryker 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
LXHNone listed
Dec 4, 2012Stryker 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
LXHNone listed
Nov 19, 2012Stryker 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
LXHNone listed
Nov 19, 2012Stryker 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
LXHNone listed
Nov 19, 2012Stryker 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
LXHNone listed
Oct 29, 2012Stryker 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
LXHNone listed
Oct 29, 2012Linvatec 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
LXHNone listed
Oct 18, 2012Aesculap, Inc.
Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
Terminated
LXHNone listed
Sep 14, 2012Tedan 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
LXHNone listed
Aug 6, 2012Linvatec 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
LXHNone listed
Aug 6, 2012Linvatec 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
LXHNone listed
Jul 26, 2012Stryker 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
LXHNone listed
Jul 19, 2012Stryker 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
LXHNone listed
Jun 6, 2012Smith & 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
LXHNone listed
Jun 6, 2012Smith & 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
LXHNone listed
Jun 6, 2012Smith & Nephew Inc
3.2 MM TROCAR, REF 71751136, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
Terminated
LXHNone listed
Jun 6, 2012Smith & 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
LXHNone listed
Jun 6, 2012Smith & 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
LXHNone listed
Jun 6, 2012Smith & 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
LXHNone listed
Jun 6, 2012Smith & 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
LXHNone listed
Jun 6, 2012Smith & 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
LXHNone listed
Jun 6, 2012Smith & 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
LXHNone listed
Jun 6, 2012Smith & 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
LXHNone listed
May 17, 2012Stryker 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
LXHNone listed
Apr 19, 2012Medtronic 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
LXHNone listed
Apr 19, 2012Medtronic 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
LXHNone listed
Apr 19, 2012Medtronic 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
LXHNone listed
Apr 16, 2012DePuy 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
LXHNone listed
Apr 16, 2012DePuy 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
LXHNone listed
Mar 22, 2012Stryker 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
LXHNone listed
Mar 19, 2012Biomet 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
LXHNone listed
Mar 19, 2012Biomet 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
LXHNone listed
Jan 18, 2012Stryker 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
LXHNone listed
Nov 2, 2011Encore 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
LXHNone listed
Nov 2, 2011Encore 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
LXHNone listed
Sep 30, 2011Biomet, 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
LXHK023063
Aug 31, 2011DePuy 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
LXHNone listed

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