Wright Medical Technology, Inc.
Medical device manufacturer in Memphis, TN.
1510(k) clearances
0PMA approvals
136recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K221645 | PROstep(TM) MIS 5mm Chamfer Screw SystemHWC · Abbreviated | 02/17/2023SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1477-2024 Class II | stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplastyStryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks.… | 03/06/2024Open, Classified |
| Z-2105-2023 Class II | Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to… | 06/13/2023Open, Classified |
| Z-1467-2023 Class II | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixationTwo lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. | 04/10/2023Open, Classified |
| Z-1466-2023 Class II | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixationTwo lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. | 04/10/2023Open, Classified |
| Z-1170-2023 Class II | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation deviceStryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these… | 02/02/2023Open, Classified |
| Z-1169-2023 Class II | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation deviceStryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these… | 02/02/2023Open, Classified |
| Z-0140-2023 Class II | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF…The tibial tray lock detail is oversized (larger than specification). | 09/30/2022Open, Classified |
| Z-0139-2023 Class II | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF…The tibial tray lock detail is oversized (larger than specification). | 09/30/2022Open, Classified |
| Z-0006-2023 Class II | stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE…The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm… | 08/03/2022Open, Classified |
| Z-0005-2023 Class II | stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE…The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm… | 08/03/2022Open, Classified |
| Z-1567-2022 Class II | Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF…An incorrect sizing label was applied to the carton packaging. | 07/27/2022Open, Classified |
| Z-1366-2022 Class II | Wright EVOLVE TRIAD Plate Cutter, REF 49510120The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped… | 06/14/2022Open, Classified |
| Z-1291-2022 Class II | Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an…The instrument is incorrectly color coded. | 06/02/2022Open, Classified |
| Z-0853-2022 Class II | EasyFuse Dynamic Compression System Instrument PackThe drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. | 03/10/2022Terminated |
| Z-0786-2022 Class II | Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008…An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw. | 02/15/2022Terminated |
| Z-0679-2022 Class II | The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of…Product was labelled with the incorrect manufacturing and distribution dates. | 02/09/2022Terminated |
| Z-0401-2022 Class II | Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a…Incorrect product is contained in the packaging. | 12/03/2021Open, Classified |
| Z-0393-2022 Class II | Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.The incorrect product is contained in the packaging. | 12/03/2021Open, Classified |
| Z-0392-2022 Class II | Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.The incorrect product is contained in the packaging. | 12/03/2021Open, Classified |
| Z-0316-2022 Class II | INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUSThe package contents and package labeling do not match. | 11/04/2021Terminated |
| Z-0315-2022 Class II | INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUSThe package contents and package labeling do not match. | 11/04/2021Terminated |
| Z-2989-2020 Class II | EVOLVE STEM 8.5MM Model # 496S085Lack of sterility assurance | 08/26/2020Terminated |
| Z-2797-2020 Class II | Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical…Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. | 07/28/2020Terminated |
| Z-2796-2020 Class II | Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware…Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. | 07/28/2020Terminated |
| Z-1924-2020 Class II | WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage:…One lot of INBONE Tibial Trays is missing the plasma coating. | 04/09/2020Terminated |
| Z-1102-2020 Class II | WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and… | 12/27/2019Terminated |
| Z-1101-2020 Class II | WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and… | 12/27/2019Terminated |
| Z-1376-2018 Class II | WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm…Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. | 03/14/2018Terminated |
| Z-1375-2018 Class II | WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm…Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. | 03/14/2018Terminated |
| Z-0573-2020 Class II | CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0572-2020 Class II | SWANSON TRAPEZIUM IMPLANT, Part Number 4520002The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0571-2020 Class II | SWANSON FINGER JOINT #2, Part Number 4700002The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0570-2020 Class II | SWANSON FINGER JOINT #1, Part Number 4700001The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0569-2020 Class II | EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0568-2020 Class II | Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0567-2020 Class II | Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032SThe firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0566-2020 Class II | VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0565-2020 Class II | INBONE STEM, TIBIAL, TOP, Part Number 200011901The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0564-2020 Class II | PRO-STIM 10cc INJECTABLE, Part Number 86SR0410The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0563-2020 Class II | ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-0562-2020 Class II | SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104The firm discovered a lack of adequate documentation confirming sterility on certain products. | 11/08/2016Terminated |
| Z-2542-2015 Class II | CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10…These screws have a potential of passing through the plate in the case when torque is applied in excessive… | 07/21/2015Terminated |
| Z-2541-2015 Class II | CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm…These screws have a potential of passing through the plate in the case when torque is applied in excessive… | 07/21/2015Terminated |
| Z-1627-2015 Class II | PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1…The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 04/16/2015Terminated |
| Z-1626-2015 Class II | PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1…The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 04/16/2015Terminated |
| Z-1625-2015 Class II | PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1…The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 04/16/2015Terminated |
| Z-1624-2015 Class II | PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1…The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 04/16/2015Terminated |
| Z-1500-2015 Class II | CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1499-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1498-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1497-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1496-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1495-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1494-2015 Class II | CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1493-2015 Class II | CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1492-2015 Class II | CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1491-2015 Class II | CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1490-2015 Class II | CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1489-2015 Class II | CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R.…The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1488-2015 Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L.…The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1487-2015 Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R.…The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1486-2015 Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L.…The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1485-2015 Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R.…The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1484-2015 Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L. Orthopedic…The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1483-2015 Class II | CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-1482-2015 Class II | CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use.The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification… | 03/06/2015Terminated |
| Z-2608-2014 Class II | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2607-2014 Class II | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2605-2014 Class II | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2604-2014 Class II | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2603-2014 Class II | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2602-2014 Class II | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2601-2014 Class II | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2600-2014 Class II | CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-2599-2014 Class II | CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON…Plates manufactured from an incorrect raw material. | 07/30/2014Terminated |
| Z-0185-2013 Class II | Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000…There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. | 09/05/2012Terminated |
| Z-0184-2013 Class II | Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT…There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. | 09/05/2012Terminated |
| Z-0183-2013 Class II | Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080…There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. | 09/05/2012Terminated |
| Z-1485-2012 | VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc.…The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage. | 04/05/2012Terminated |
| Z-1484-2012 | VALOR(R), TARGETING GUIDE, REF 4150011000, Wright Medical Technology, Inc., 5677…The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage. | 04/05/2012Terminated |
| Z-1031-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 76mm GROUP K, REF DSBFGK76, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1030-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 74mm GROUP J, REF DSBFGJ74, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1029-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 72mm GROUP J, REF DSBFGJ72, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1028-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 70mm GROUP J, REF DSBFGJ70, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1027-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 68mm GROUP H, REF DSBFGH68, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1026-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 66mm GROUP H, REF DSBFGH66, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1025-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 64mm GROUP H, REF DSBFGH64, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1024-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 62mm GROUP G, REF DSBFGG62, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1023-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 60mm GROUP G, REF DSBFGG60, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1022-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 58mm GROUP G, REF DSBFGG58, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1021-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 56mm GROUP F, REF DSBFGF56, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1020-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1019-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 52mm GROUP D, REF DSBFGD52, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1018-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 50mm GROUP C, REF DSBFGC50, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1017-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 48mm GROUP B, REF DSBFGB48, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1016-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 46mm GROUP B, REF DSBFGB46, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-0067-2012 | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 7.5mm, 2 SUTURE, REF 5100-0020…The product is labeled with an expiration date without adequate justification. | 09/20/2011Terminated |
| Z-0066-2012 | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 5.0mm, 2 SUTURE, REF 5100-0018…The product is labeled with an expiration date without adequate justification. | 09/20/2011Terminated |
| Z-0065-2012 | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 5.0mm, 0 SUTURE, REF 5100-0016…The product is labeled with an expiration date without adequate justification. | 09/20/2011Terminated |
| Z-0064-2012 | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 2 SUTURE, REF 5100-0014…The product is labeled with an expiration date without adequate justification. | 09/20/2011Terminated |
| Z-0063-2012 | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 0 SUTURE, REF 5100-0012…The product is labeled with an expiration date without adequate justification. | 09/20/2011Terminated |
| Z-0062-2012 | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2 SUTURE, REF 5100-0010…The product is labeled with an expiration date without adequate justification. | 09/20/2011Terminated |
| Z-0061-2012 | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 0 SUTURE, REF 5100-008, 1…The product is labeled with an expiration date without adequate justification. | 09/20/2011Terminated |
| Z-0060-2012 | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2.0 SUTURE, REF 5100-006…The product is labeled with an expiration date without adequate justification. | 09/20/2011Terminated |
| Z-0059-2012 | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 0 SUTURE, REF 5100-004,1…The product is labeled with an expiration date without adequate justification. | 09/20/2011Terminated |
| Z-0058-2012 | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002…The product is labeled with an expiration date without adequate justification. | 09/20/2011Terminated |
| Z-2590-2011 | ENDO-FUSE(TM) FUSION ROD, 7 mm X 70 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF:…Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm.… | 04/20/2011Terminated |
| Z-2589-2011 | ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF:…Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm.… | 04/20/2011Terminated |
| Z-1525-2011 | TI ANCHOR 2.5MM W / 2-0 SUTURE, G-FORCE (R) SUTURE ANCHOR, Tissue Anchor, REF 86TA-2520…Driver may break during use. | 01/11/2011Terminated |
| Z-1524-2011 | TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, Rx…Driver may break during use. | 01/11/2011Terminated |
| Z-2470-2010 | DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1…After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake. | 08/26/2010Terminated |
| Z-2212-2010 | DYNASTY A-CLASS POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36…The inner and outer product packaging was missing the following information: shelf life, translations… | 06/07/2010Terminated |
| Z-2188-2010 | CLAW HEX SCREW CHARLOTTE " F&A SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw ... IMPLANT…One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws. | 06/07/2010Terminated |
| Z-1779-2010 | RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical…Drill guides from 2 lots may not seat properly on the compression block. | 04/08/2010Terminated |
| Z-1215-2010 | ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE…The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of… | 02/19/2010Terminated |
| Z-1637-2010 | ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM…The left medial pivot and right medial pivot inserts were co-mingled | 11/24/2009Terminated |
| Z-1636-2010 | ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT, THICKNESS 12MM…The left medial pivot and right medial pivot inserts were co-mingled | 11/24/2009Terminated |
| Z-0493-2010 | ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-2140, DIAMETER 13mm, LENGTH 140mm, 1…Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy… | 09/22/2009Terminated |
| Z-0492-2010 | ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-0140, DIAMETER 11mm, LENGTH 140mm, 1…Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy… | 09/22/2009Terminated |
| Z-1716-2009 | CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length:…Incorrect packaging, swapped sizes | 05/14/2009Terminated |
| Z-1715-2009 | CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length:…Incorrect packaging, swapped sizes | 05/14/2009Terminated |
| Z-1208-2009 | Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant…The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam… | 02/19/2009Terminated |
| Z-2218-2008 | Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx only, Non-Sterile, 1 each…Trials are 2.5mm larger than marked. | 05/20/2008Terminated |
| Z-2217-2008 | Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, Rx only, Non-Sterile, 1 each…Trials are 2.5mm larger than marked. | 05/20/2008Terminated |
| Z-2216-2008 | Dynasty Trial Shell 64mm OD, Group H, REF 3300-GH64, Rx only, Non-Sterile, 1 each…Trials are 2.5mm larger than marked. | 05/20/2008Terminated |
| Z-2215-2008 | Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Wright…Trials are 2.5mm larger than marked. | 05/20/2008Terminated |
| Z-0290-2008 | Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright…Breakage: breaking of the connecting foot that is on the distal surface of the instrument | 10/04/2007Terminated |
| Z-0868-2007 | Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless…The titanium plasma coating was found to have missing fragments. | 03/27/2007Terminated |
| Z-0867-2007 | Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364…The titanium plasma coating was found to have missing fragments. | 03/27/2007Terminated |
| Z-0573-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3655, Size 55mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |
| Z-0572-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |
| Z-0571-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3653, Size 53mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |
| Z-0570-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3652, Size 52mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |
| Z-0569-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |
| Z-0568-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |
| Z-0567-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm…Product specification failure which could result in improper locking of the cup onto the femoral head. | 01/03/2007Terminated |