T2
Holding Sleeve for Screwdrivers Diam.4.5,5.0,6.5mm
17manufacturers in China registered for this device type
1,373catalogue numbers in this listing
12510(k) clearances naming this product code
37recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-09-24 |
| Record revised | 2025-04-14 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 18 to 780 mm; angle 125 °; width 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1847-1348S | Diameter: 13.0 Millimeter | In distribution |
| 1828-0944S | Length 440.0 mm | In distribution |
| 2339-1028S | Diameter: 10.0 Millimeter | In distribution |
| 1850-0942S | Diameter: 9.0 Millimeter | In distribution |
| 1830-0718S | Length 180.0 mm | In distribution |
| 1825-0001S | In distribution | |
| 2339-0920S | Diameter: 9.0 Millimeter | In distribution |
| 1822-1533S | Diameter: 15.0 Millimeter | In distribution |
| 1846-1130S | Angle 125.0 ° | In distribution |
| 1845-0940S | Length 400.0 mm | In distribution |
| 1825-1220S | Diameter: 12.0 Millimeter | In distribution |
| 1825-1032S | Diameter: 10.0 Millimeter | In distribution |
| 1843-1242S | Angle 125.0 ° | In distribution |
| 2311-1222S | Diameter: 12.0 Millimeter | In distribution |
| 1825-1238S | Diameter: 12.0 Millimeter | In distribution |
| 1829-2078S | Diameter: 10.0 Millimeter | In distribution |
| 1826-1320S | Diameter: 13.0 Millimeter | In distribution |
| 0195-1500S | Diameter: 1.5 Millimeter | In distribution |
| 2339-1236S | Length 360.0 mm | In distribution |
| 2339-1232S | Length 320.0 mm | In distribution |
| 2313-0724S | Diameter: 7.0 Millimeter | In distribution |
| 0194-4000 | Diameter: 4.0 Millimeter | In distribution |
| 1850-0025S | In distribution | |
| 1825-1426S | Length 260.0 mm | In distribution |
| 1843-1134S | Diameter: 11.0 Millimeter | In distribution |
| 1850-1336S | Length 360.0 mm | In distribution |
| 1851-1336S | Diameter: 13.0 Millimeter | In distribution |
| 1846-0946S | Length 460.0 mm | In distribution |
| 1825-1226S | Diameter: 12.0 Millimeter | In distribution |
| 1845-1530S | Angle 125.0 ° | In distribution |
| 1843-1546S | Length 460.0 mm | In distribution |
| 1824-1025S | Diameter: 10.0 Millimeter | In distribution |
| 1828-1336S | Length 360.0 mm | In distribution |
| 1830-0723S | Length 230.0 mm | In distribution |
| 1824-1033S | Diameter: 10.0 Millimeter | In distribution |
| 1843-1234S | Diameter: 12.0 Millimeter | In distribution |
| 1832-2826S | Diameter: 8.0 Millimeter | In distribution |
| 1850-1540S | Length 400.0 mm | In distribution |
| 1825-1242S | Diameter: 12.0 Millimeter | In distribution |
| 1825-1216S | Diameter: 12.0 Millimeter | In distribution |
| 1851-1130S | Length 300.0 mm | In distribution |
| 1897-6080S | Diameter: 6.5 Millimeter | In distribution |
| 1850-1536S | Length 360.0 mm | In distribution |
| 2339-0926S | Diameter: 9.0 Millimeter | In distribution |
| 1851-1032S | Diameter: 10.0 Millimeter | In distribution |
| 1850-1226S | Diameter: 12.0 Millimeter | In distribution |
| 1845-1048S | Diameter: 10.0 Millimeter | In distribution |
| 1822-1036S | Diameter: 10.0 Millimeter | In distribution |
| 1843-1030S | Diameter: 10.0 Millimeter | In distribution |
| 1845-1526S | Diameter: 15.0 Millimeter | In distribution |
| 2311-0919S | Side: LEFT | In distribution |
| 1850-1136S | Diameter: 11.0 Millimeter | In distribution |
| 1830-0920S | Diameter: 9.0 Millimeter | In distribution |
| 1846-1128S | Diameter: 11.0 Millimeter | In distribution |
| 1850-1340S | Diameter: 13.0 Millimeter | In distribution |
| 2339-1124S | Diameter: 11.0 Millimeter | In distribution |
| 1843-1038S | Diameter: 10.0 Millimeter | In distribution |
| 1822-0830S | Diameter: 8.0 Millimeter | In distribution |
| 1830-0832S | Length 320.0 mm | In distribution |
| 1851-0828S | Length 280.0 mm | In distribution |
| 1822-1340S | Diameter: 13.0 Millimeter | In distribution |
| 1822-1040S | Length 405.0 mm | In distribution |
| 2313-1027S | Diameter: 10.0 Millimeter | In distribution |
| 2339-1146S | Diameter: 11.0 Millimeter | In distribution |
| 1826-1317S | Length 170.0 mm | In distribution |
| 1847-1532S | Length 320.0 mm | In distribution |
| 2313-1224S | Length 240.0 mm | In distribution |
| 1847-0936S | Angle 125.0 ° | In distribution |
| 1825-0930S | Length 300.0 mm | In distribution |
| 0195-1750S | Diameter: 1.75 Millimeter | In distribution |
| 0194-2250S | Length 300.0 mm | In distribution |
| 1851-0926S | Diameter: 9.0 Millimeter | In distribution |
| 1847-1538S | Diameter: 15.0 Millimeter | In distribution |
| 1845-1044S | Angle 125.0 ° | In distribution |
| 1818-1220S | Diameter: 12.0 Millimeter | In distribution |
| 1828-1032S | Length 320.0 mm | In distribution |
| 1832-2830S | Diameter: 8.0 Millimeter | In distribution |
| 2313-0815S | Diameter: 8.0 Millimeter | In distribution |
| 1825-1538S | Diameter: 15.0 Millimeter | In distribution |
| 2353-1104 | In distribution | |
| 0194-2500S | Length 450.0 mm | In distribution |
| 1850-0003S | In distribution | |
| 1846-1536S | Diameter: 15.0 Millimeter | In distribution |
| 1851-1038S | Length 380.0 mm | In distribution |
| 1851-1530S | Diameter: 15.0 Millimeter | In distribution |
| 1843-1146S | Angle 125.0 ° | In distribution |
| 1822-1048S | Diameter: 10.0 Millimeter | In distribution |
| 1846-0944S | Diameter: 9.0 Millimeter | In distribution |
| 1824-1034S | Length 345.0 mm | In distribution |
| 1828-1046S | Diameter: 10.0 Millimeter | In distribution |
| 2355-3920 | In distribution | |
| 1828-1036S | Diameter: 10.0 Millimeter | In distribution |
| 1850-1142S | Length 420.0 mm | In distribution |
| 1851-1426S | Diameter: 14.0 Millimeter | In distribution |
| 1845-1136S | Angle 125.0 ° | In distribution |
| 1828-1534S | Length 340.0 mm | In distribution |
| 1830-0025S | In distribution | |
| 1825-0916S | Length 160.0 mm | In distribution |
| 1851-0836S | Length 360.0 mm | In distribution |
| 1825-1548S | Length 480.0 mm | In distribution |
| 1850-1438S | Length 380.0 mm | In distribution |
| 1826-1226S | Diameter: 12.0 Millimeter | In distribution |
| 2313-0821S | Length 210.0 mm | In distribution |
| 1825-1522S | Diameter: 15.0 Millimeter | In distribution |
| 1822-1525S | Length 255.0 mm | In distribution |
| 1822-1330S | Diameter: 13.0 Millimeter | In distribution |
| 1806-1409 | In distribution | |
| 1828-1240S | Length 400.0 mm | In distribution |
| 1850-1024S | Diameter: 10.0 Millimeter | In distribution |
| 1825-0826S | Length 260.0 mm | In distribution |
| 1843-1048S | Length 480.0 mm | In distribution |
| 1851-1128S | Length 280.0 mm | In distribution |
| 1851-1528S | Diameter: 15.0 Millimeter | In distribution |
| 1822-1028S | Length 285.0 mm | In distribution |
| 1851-1328S | Diameter: 13.0 Millimeter | In distribution |
| 1828-1332S | Length 320.0 mm | In distribution |
| 1850-1548S | Length 480.0 mm | In distribution |
| 1850-1246S | Diameter: 12.0 Millimeter | In distribution |
| 1851-1224S | Length 240.0 mm | In distribution |
| 1830-0728S | Length 280.0 mm | In distribution |
| 1825-1338S | Length 380.0 mm | In distribution |
| 1828-1126S | Diameter: 11.0 Millimeter | In distribution |
| 1828-1140S | Length 400.0 mm | In distribution |
| 1847-1546S | Angle 125.0 ° | In distribution |
| 1850-1144S | Diameter: 11.0 Millimeter | In distribution |
| 1818-1215S | Length 150.0 mm | In distribution |
| 1829-1370S | Length 700.0 mm | In distribution |
| 1896-5040 | Length 40.0 mm | In distribution |
| 1825-1540S | Length 400.0 mm | In distribution |
| 1822-1137S | Length 375.0 mm | In distribution |
| 1826-1128S | Diameter: 11.0 Millimeter | In distribution |
| 2339-0917S | Diameter: 9.0 Millimeter | In distribution |
| 2339-1032S | Length 320.0 mm | In distribution |
| 1826-0926S | Length 260.0 mm | In distribution |
| 1825-1140S | Length 400.0 mm | In distribution |
| 1822-1140S | Length 405.0 mm | In distribution |
| 1896-5060 | Diameter: 5.0 Millimeter | In distribution |
| 1822-0939S | Diameter: 9.0 Millimeter | In distribution |
| 1806-1412 | In distribution | |
| 1822-1130S | Length 300.0 mm | In distribution |
| 1850-1442S | Diameter: 14.0 Millimeter | In distribution |
| 1828-1248S | Diameter: 12.0 Millimeter | In distribution |
| 1825-1114S | Diameter: 11.0 Millimeter | In distribution |
| 1896-5070 | Length 70.0 mm | In distribution |
| 0194-2250 | Diameter: 2.25 Millimeter | In distribution |
| 1850-1148S | Length 480.0 mm | In distribution |
| 1845-1330S | Angle 125.0 ° | In distribution |
| 1850-0838S | Diameter: 8.0 Millimeter | In distribution |
| 1828-1328S | Diameter: 13.0 Millimeter | In distribution |
| 2313-1221S | Length 210.0 mm | In distribution |
| 2339-1430S | Diameter: 14.0 Millimeter | In distribution |
| 1825-1016S | Length 160.0 mm | In distribution |
| 2339-1340S | Diameter: 13.0 Millimeter | In distribution |
| 1847-0928S | Diameter: 9.0 Millimeter | In distribution |
| 1822-1127S | Diameter: 11.0 Millimeter | In distribution |
| 1845-1540S | Length 400.0 mm | In distribution |
| 2313-0927S | Length 270.0 mm | In distribution |
| 1850-1230S | Length 300.0 mm | In distribution |
| 1830-0914S | Diameter: 9.0 Millimeter | In distribution |
| 1843-1138S | Length 380.0 mm | In distribution |
| 1819-1130S | Length 300.0 mm | In distribution |
| 1806-1408 | In distribution | |
| 2313-1024S | Diameter: 10.0 Millimeter | In distribution |
| 1850-0848S | Length 480.0 mm | In distribution |
| 1830-0720S | Length 200.0 mm | In distribution |
| 2339-1438S | Diameter: 14.0 Millimeter | In distribution |
| 1850-1528S | Length 280.0 mm | In distribution |
| 1828-0840S | Diameter: 8.0 Millimeter | In distribution |
| 1851-1040S | Diameter: 10.0 Millimeter | In distribution |
| 1896-5035 | Diameter: 5.0 Millimeter | In distribution |
| 2339-1244S | Diameter: 12.0 Millimeter | In distribution |
| 1822-1536S | Diameter: 15.0 Millimeter | In distribution |
| 1825-0848S | Length 480.0 mm | In distribution |
| 1847-0932S | Angle 125.0 ° | In distribution |
| 1845-1140S | Angle 125.0 ° | In distribution |
| 1828-1542S | Length 420.0 mm | In distribution |
| 1828-1048S | Length 480.0 mm | In distribution |
| 2339-1138S | Diameter: 11.0 Millimeter | In distribution |
| 1828-1242S | Length 420.0 mm | In distribution |
| 1845-1034S | Angle 125.0 ° | In distribution |
| 1822-0833S | Diameter: 8.0 Millimeter | In distribution |
| 1828-0926S | Diameter: 9.0 Millimeter | In distribution |
| 1830-0001S | In distribution | |
| 2311-0925S | Length 255.0 mm | In distribution |
| 2339-1217S | Diameter: 12.0 Micrometer | In distribution |
| 1847-0940S | Diameter: 9.0 Millimeter | In distribution |
| 1847-0944S | Diameter: 9.0 Millimeter | In distribution |
| 1851-1532S | Diameter: 15.0 Millimeter | In distribution |
| 1822-1324S | Diameter: 13.0 Millimeter | In distribution |
| 1829-1316S | Length 660.0 mm | In distribution |
| 1828-1030S | Diameter: 10.0 Millimeter | In distribution |
| 1822-1230S | Diameter: 12.0 Millimeter | In distribution |
| 1851-0834S | Diameter: 8.0 Millimeter | In distribution |
| 1843-1326S | Diameter: 13.0 Millimeter | In distribution |
| 1850-0844S | Diameter: 8.0 Millimeter | In distribution |
| 1845-1546S | Length 460.0 mm | In distribution |
| 1828-1246S | Length 460.0 mm | In distribution |
| 1830-0922S | Length 220.0 mm | In distribution |
| 1843-1148S | Diameter: 11.0 Millimeter | In distribution |
| 1828-1230S | Diameter: 12.0 Millimeter | In distribution |
| 1830-0831S | Diameter: 8.0 Millimeter | In distribution |
| 1843-1232S | Angle 125.0 ° | In distribution |
| 1825-1524S | Diameter: 15.0 Millimeter | In distribution |
| 1851-1334S | Diameter: 13.0 Millimeter | In distribution |
| 2313-1125S | Diameter: 11.0 Millimeter | In distribution |
| 1826-1232S | Diameter: 12.0 Millimeter | In distribution |
| 1850-0928S | Length 280.0 mm | In distribution |
| 1819-1015S | Length 150.0 mm | In distribution |
| 2311-1218S | Length 180.0 mm | In distribution |
| 1825-1418S | Length 180.0 mm | In distribution |
| 2339-1044S | Diameter: 10.0 Millimeter | In distribution |
| 1830-0824S | Length 240.0 mm | In distribution |
| 1828-0838S | Diameter: 8.0 Millimeter | In distribution |
| 1829-1128S | Length 780.0 mm | In distribution |
| 2313-0921S | Diameter: 9.0 Millimeter | In distribution |
| 1830-0929S | Length 290.0 mm | In distribution |
| 1843-1338S | Diameter: 13.0 Millimeter | In distribution |
| 2313-0828S | Length 285.0 mm | In distribution |
| 1822-1231S | Diameter: 12.0 Millimeter | In distribution |
| 1828-1144S | Length 440.0 mm | In distribution |
| 1846-1134S | Diameter: 11.0 Millimeter | In distribution |
| 1851-0946S | Diameter: 9.0 Millimeter | In distribution |
| 1826-0003S | In distribution | |
| 2313-0730S | Side: RIGHT | In distribution |
| 1825-1020S | Length 200.0 mm | In distribution |
| 1843-1336S | Angle 125.0 ° | In distribution |
| 1897-6130S | Diameter: 6.5 Millimeter | In distribution |
| 2313-0918S | Side: RIGHT | In distribution |
| 1822-1027S | Length 270.0 mm | In distribution |
| 1845-1142S | Diameter: 11.0 Millimeter | In distribution |
| 1846-1534S | Length 340.0 mm | In distribution |
| 1851-0938S | Length 380.0 mm | In distribution |
| 1828-1526S | Length 260.0 mm | In distribution |
| 1826-1428S | Diameter: 14.0 Millimeter | In distribution |
| 1825-1328S | Diameter: 13.0 Millimeter | In distribution |
| 1822-1333S | Length 330.0 mm | In distribution |
| 1824-1030S | Diameter: 10.0 Millimeter | In distribution |
| 1822-1128S | Length 285.0 mm | In distribution |
| 1825-1534S | Diameter: 15.0 Millimeter | In distribution |
| 1822-0945S | Diameter: 9.0 Millimeter | In distribution |
| 1825-1440S | Length 400.0 mm | In distribution |
| 1824-1027S | Diameter: 10.0 Millimeter | In distribution |
| 1828-1338S | Diameter: 13.0 Millimeter | In distribution |
| 1830-0931S | Diameter: 9.0 Millimeter | In distribution |
| 1850-0934S | Diameter: 9.0 Millimeter | In distribution |
| 1829-1104S | Diameter: 11.5 Millimeter | In distribution |
| 2339-1220S | Diameter: 12.0 Millimeter | In distribution |
| 1825-1432S | Diameter: 14.0 Millimeter | In distribution |
| 1843-0936S | Angle 125.0 ° | In distribution |
| 1851-0940S | Diameter: 9.0 Millimeter | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
| Precice® Bone Transport System | NuVasive Specialized Orthopedics, Inc. | 546 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261481 | 2026-06-29 |
| K253640 | 2026-02-03 |
| K251400 | 2025-08-20 |
| K250163 | 2025-08-13 |
| K230512 | 2023-06-09 |
| K222309 | 2022-11-15 |
| K213328 | 2022-02-11 |
| K203819 | 2021-02-26 |
| K200880 | 2020-07-01 |
| K112059 | 2011-08-08 |
| K915435 | 1992-03-02 |
| K912930 | 1992-01-13 |
Recalls Naming This Product
20 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker GmbH | UDI-DI | 2025-05-22 | Class II | Under Investigation by firm | Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail. | 1 | |
| Stryker GmbH | UDI-DI | 2025-05-22 | Class II | Under Investigation by firm | Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail. | 2 | |
| Stryker GmbH | UDI-DI | 2021-05-27 | Class II | Process control | The devices have a different inner diameter than the diameter specified on the outer box label. | 52 | |
| Stryker GmbH | UDI-DI | 2021-05-27 | Class II | Process control | The devices have a different inner diameter than the diameter specified on the outer box label. | 242 | |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 12 | 2020-05-21 |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2 | 2020-05-21 |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 17 | 2020-05-21 |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 9 | 2020-05-21 |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 1 | 2020-05-21 |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 7 | 2020-05-21 |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| Stryker GmbH | UDI-DI | 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 |
Recalls
17 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-05-28 | Class II | Process design | Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. | ||
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | 186 OUS | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US 76; OUS 290 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | 56 OUS | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | OUS 40 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | OUS 400 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US 3; OUS 2 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US 3; OUS 1 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | OUS: 1404 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | 26 OUS | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US 46; OUS 314 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US:127; OUS 454 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | OUS 121 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US 3; OUS 13 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | 69 OUS | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | 109 OUS | 2023-09-21 |
| 2018-06-27 | Class II | Packaging process control | Incomplete seal on the Tyvek lid may compromise the sterility of the device | 38 | 2020-04-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.