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Wright Medical Technology, Inc. FDA Recalls
21 recalls on file across devices, 0 of them Class I and 14 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplastyClass IIMar 6, 2024Stryker has identified an issue that impacts specific lots o |
| Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.Class IIJun 13, 2023The devices were manufactured with the pin sleeve holes too |
| stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixationClass IIApr 10, 2023Two lots of Ortholoc 3Di Fusion plates contain incorrect dor |
| stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixationClass IIApr 10, 2023Two lots of Ortholoc 3Di Fusion plates contain incorrect dor |
| ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation deviceClass IIFeb 2, 2023Stryker has identified an issue that impacts two specific lo |
| ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation deviceClass IIFeb 2, 2023Stryker has identified an issue that impacts two specific lo |
| Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3Class IISep 30, 2022The tibial tray lock detail is oversized (larger than specif |
| Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4Class IISep 30, 2022The tibial tray lock detail is oversized (larger than specif |
| stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and RepaiClass IIAug 3, 2022The outer label does not match the device inside the package |
| stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and RepClass IIAug 3, 2022The outer label does not match the device inside the package |
| Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.Class IIJul 27, 2022An incorrect sizing label was applied to the carton packagin |
| Wright EVOLVE TRIAD Plate Cutter, REF 49510120Class IIJun 14, 2022The plate cutter is unable to meet sterilization requirement |
| Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINIClass IIJun 2, 2022The instrument is incorrectly color coded. |
| EasyFuse Dynamic Compression System Instrument PackClass IIMar 10, 2022The drill and adjustable drill guide can jam/bind intraopera |
| Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORClass IIFeb 15, 2022An incorrect screw is packaged in the product, which contain |
| The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plaClass IIFeb 9, 2022Product was labelled with the incorrect manufacturing and di |
| Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.Class IIDec 3, 2021The incorrect product is contained in the packaging. |
| Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE LisfClass IIDec 3, 2021Incorrect product is contained in the packaging. |
| Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.Class IIDec 3, 2021The incorrect product is contained in the packaging. |
| INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUSClass IINov 4, 2021The package contents and package labeling do not match. |
| INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUSClass IINov 4, 2021The package contents and package labeling do not match. |