FDA Device Recalls

Recalls / Firms / Wright Medical Technology, Inc.

Wright Medical Technology, Inc.

140 FDA device recalls on record.

DateClassProductReason
2024-03-06—stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
2023-06-13—Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
2023-04-10—stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
2023-04-10—stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
2023-02-02—ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
2023-02-02—ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
2022-09-30—Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, S
2022-09-30—Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, S
2022-08-03—stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus
2022-08-03—stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus R
2022-07-27—Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
2022-06-14—Wright EVOLVE TRIAD Plate Cutter, REF 49510120
2022-06-02—Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument
2022-03-10—EasyFuse Dynamic Compression System Instrument Pack
2022-02-15—Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a
2022-02-09—The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatibl
2021-12-03—Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
2021-12-03—Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.
2021-12-03—Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component o
2021-11-04—INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
2021-11-04—INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
2020-08-26—EVOLVE STEM 8.5MM Model # 496S085
2020-07-28—Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit
2020-07-28—Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware remov
2020-04-09—WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended
2019-12-27—WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
2019-12-27—WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
2018-03-14—WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
2018-03-14—WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
2016-11-08—VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045
2016-11-08—PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
2016-11-08—CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
2016-11-08—Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
2016-11-08—EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
2016-11-08—SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
2016-11-08—SWANSON FINGER JOINT #1, Part Number 4700001
2016-11-08—SWANSON TRAPEZIUM IMPLANT, Part Number 4520002
2016-11-08—SWANSON FINGER JOINT #2, Part Number 4700002
2016-11-08—INBONE STEM, TIBIAL, TOP, Part Number 200011901
2016-11-08—Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S
2016-11-08—ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
2015-07-21—CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP
2015-07-21—CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3
2015-04-16—PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY
2015-04-16—PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY
2015-04-16—PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY
2015-04-16—PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY
2015-03-06—CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.
2015-03-06—CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.
2014-07-30—CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthope
2014-07-30—CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthope
2014-07-30—CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE Orthope
2014-07-30—CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthoped
2014-07-30—CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE
2014-07-30—CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130,
2014-07-30—CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE
2014-07-30—CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE
2014-07-30—CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthope
2012-09-05—Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 P
2012-09-05—Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers:
2012-09-05—Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X063912
2012-04-05—VALOR(R), TARGETING GUIDE, REF 4150011000, Wright Medical Technology, Inc., 5677 Airline, Road, Arli
2012-04-05—VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline,
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 70mm GROUP J, REF DSBFGJ70, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 68mm GROUP H, REF DSBFGH68, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 56mm GROUP F, REF DSBFGF56, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 50mm GROUP C, REF DSBFGC50, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 46mm GROUP B, REF DSBFGB46, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 64mm GROUP H, REF DSBFGH64, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 58mm GROUP G, REF DSBFGG58, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 62mm GROUP G, REF DSBFGG62, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 76mm GROUP K, REF DSBFGK76, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 66mm GROUP H, REF DSBFGH66, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 74mm GROUP J, REF DSBFGJ74, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 60mm GROUP G, REF DSBFGG60, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 52mm GROUP D, REF DSBFGD52, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 72mm GROUP J, REF DSBFGJ72, Rx ONLY, STERILE R, Wright Medical T
2012-01-03—DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 48mm GROUP B, REF DSBFGB48, Rx ONLY, STERILE R, Wright Medical T
2011-09-20—ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 2 SUTURE, REF 5100-0014, 1 each, STER
2011-09-20—ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 0 SUTURE, REF 5100-004,1 each, STERIL
2011-09-20—ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2 SUTURE, REF 5100-0010, 1 each, STER
2011-09-20—ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002, 1 each, STE
2011-09-20—ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 0 SUTURE, REF 5100-0012, 1 each, STER
2011-09-20—ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 0 SUTURE, REF 5100-008, 1 each, STERI
2011-09-20—ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 5.0mm, 2 SUTURE, REF 5100-0018, 1 each, STER
2011-09-20—ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 7.5mm, 2 SUTURE, REF 5100-0020, 1 each, STER
2011-09-20—ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2.0 SUTURE, REF 5100-006, 1 each, STE
2011-09-20—ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 5.0mm, 0 SUTURE, REF 5100-0016, 1 each, STER
2011-04-20—ENDO-FUSE(TM) FUSION ROD, 7 mm X 70 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005970,
2011-04-20—ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005950,
2011-01-11—TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, Rx ONLY, Steri
2011-01-11—TI ANCHOR 2.5MM W / 2-0 SUTURE, G-FORCE (R) SUTURE ANCHOR, Tissue Anchor, REF 86TA-2520, Rx ONLY, St
2010-08-26—DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx O
2010-06-07—DYNASTY A-CLASS POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o
2010-06-07—CLAW HEX SCREW CHARLOTTE " F&A SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw ... IMPLANT MATERIA
2010-04-08—RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsm
2010-02-19—ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH
2009-11-24—ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STE
2009-11-24—ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, ST
2009-09-22—ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-2140, DIAMETER 13mm, LENGTH 140mm, 1 EACH, STER
2009-09-22—ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-0140, DIAMETER 11mm, LENGTH 140mm, 1 EACH, STER
2009-05-14—CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper
2009-05-14—CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length: +3.5mm, Taper
2009-02-19—Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF:
2008-05-20—Dynasty Trial Shell 64mm OD, Group H, REF 3300-GH64, Rx only, Non-Sterile, 1 each, Wright Medical Te
2008-05-20—Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, Rx only, Non-Sterile, 1 each, Wright Medical Te
2008-05-20—Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Wright Medical Techno
2008-05-20—Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx only, Non-Sterile, 1 each, Wright Medical Te
2007-10-04—Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology
2007-03-27—Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium P
2007-03-27—Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Ti
2007-01-03—Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm O.D., use wi
2007-01-03—Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3653, Size 53mm O.D., use wi
2007-01-03—Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm O.D., use wi
2007-01-03—Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3652, Size 52mm O.D., use wi
2007-01-03—Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm O.D., use wi
2007-01-03—Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3655, Size 55mm O.D., use wi
2007-01-03—Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D., use wi
2006-01-03—Guardian Distal Femur Axial Pin
2004-07-14—Guardian Distal Femur Axial Pin
2004-07-02—Achillon minimally invasive Achilles tendon suture system
2003-08-18—Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total