| 2024-03-06 |
Class II
|
Ongoing |
Z-1477-2024 |
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty |
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Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have … |
| 2023-06-13 |
Class II
|
Ongoing |
Z-2105-2023 |
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. |
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The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventi… |
| 2023-04-10 |
Class II
|
Ongoing |
Z-1467-2023 |
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation |
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Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. |
| 2023-04-10 |
Class II
|
Ongoing |
Z-1466-2023 |
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation |
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Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. |
| 2023-02-02 |
Class II
|
Ongoing |
Z-1170-2023 |
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device |
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Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting… |
| 2023-02-02 |
Class II
|
Ongoing |
Z-1169-2023 |
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device |
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Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting… |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0140-2023 |
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4 |
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The tibial tray lock detail is oversized (larger than specification). |
| 2022-09-30 |
Class II
|
Ongoing |
Z-0139-2023 |
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3 |
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The tibial tray lock detail is oversized (larger than specification). |
| 2022-08-03 |
Class II
|
Ongoing |
Z-0006-2023 |
stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Rep… |
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The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected… |
| 2022-08-03 |
Class II
|
Ongoing |
Z-0005-2023 |
stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repai… |
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The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected… |
| 2022-07-27 |
Class II
|
Ongoing |
Z-1567-2022 |
Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile. |
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An incorrect sizing label was applied to the carton packaging. |
| 2022-06-14 |
Class II
|
Ongoing |
Z-1366-2022 |
Wright EVOLVE TRIAD Plate Cutter, REF 49510120 |
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The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilizat… |
| 2022-06-02 |
Class II
|
Ongoing |
Z-1291-2022 |
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINI… |
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The instrument is incorrectly color coded. |
| 2022-03-10 |
Class II
|
Terminated |
Z-0853-2022 |
EasyFuse Dynamic Compression System Instrument Pack |
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The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. |
| 2022-02-15 |
Class II
|
Terminated |
Z-0786-2022 |
Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the OR… |
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An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw. |
| 2022-02-09 |
Class II
|
Terminated |
Z-0679-2022 |
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The pla… |
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Product was labelled with the incorrect manufacturing and distribution dates. |
| 2021-12-03 |
Class II
|
Ongoing |
Z-0401-2022 |
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisf… |
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Incorrect product is contained in the packaging. |
| 2021-12-03 |
Class II
|
Ongoing |
Z-0393-2022 |
Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. |
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The incorrect product is contained in the packaging. |
| 2021-12-03 |
Class II
|
Ongoing |
Z-0392-2022 |
Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430. |
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The incorrect product is contained in the packaging. |
| 2021-11-04 |
Class II
|
Terminated |
Z-0316-2022 |
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS |
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The package contents and package labeling do not match. |
| 2021-11-04 |
Class II
|
Terminated |
Z-0315-2022 |
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS |
— |
The package contents and package labeling do not match. |
| 2020-08-26 |
Class II
|
Terminated |
Z-2989-2020 |
EVOLVE STEM 8.5MM Model # 496S085 |
— |
Lack of sterility assurance |
| 2020-07-28 |
Class II
|
Terminated |
Z-2797-2020 |
Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed t… |
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Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. |
| 2020-07-28 |
Class II
|
Terminated |
Z-2796-2020 |
Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facil… |
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Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. |
| 2020-04-09 |
Class II
|
Terminated |
Z-1924-2020 |
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient li… |
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One lot of INBONE Tibial Trays is missing the plasma coating. |