Stryker GmbH
Stryker GmbH appears in FDA public data with 77 recalls, 271 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2832-2026, Class II) was initiated on July 1, 2026. Its most recent 510(k) clearance was granted on June 29, 2026.
Summary
- Total Recalls
- 77
- 510(k) Clearances
- 271
- Inspections
- 7
- Compliance Actions
- 0
Known Names
physio control international, stryker-corporation, physio control, stryker medical, stryker leibinger gmbh co kg, stryker craniomaxillofacial, mako surgical, wright medical group, k2m group holdings, stryker-instruments
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2832-2026 | Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. | July 1, 2026 |
| Z-2831-2026 | Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. | July 1, 2026 |
| Z-2830-2026 | Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. | July 1, 2026 |
| Z-2833-2026 | Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. | July 1, 2026 |
| Z-2827-2026 | Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. | July 1, 2026 |
| Z-2828-2026 | Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. | July 1, 2026 |
| Z-2829-2026 | Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. | July 1, 2026 |
| Z-1914-2025 | Class II | Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S. | May 28, 2025 |
| Z-1940-2025 | Class II | Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. | May 22, 2025 |
| Z-1939-2025 | Class II | Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. | May 22, 2025 |
| Z-1620-2025 | Class II | Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; | March 28, 2025 |
| Z-1621-2025 | Class II | Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; | March 28, 2025 |
| Z-2219-2024 | Class II | Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System. | May 9, 2024 |
| Z-1084-2024 | Class II | Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm | December 6, 2023 |
| Z-1085-2024 | Class II | Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm | December 6, 2023 |
| Z-1191-2023 | Class II | stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device | February 7, 2023 |
| Z-1011-2022 | Class II | Smart Toe II Intramedullary Arthrodesis Implant | March 28, 2022 |
| Z-2171-2021 | Class II | Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S | May 27, 2021 |
| Z-2170-2021 | Class II | Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S | May 27, 2021 |
| Z-0457-2021 | Class II | Osteosynthesis Compression Staple EasyClip | September 25, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K261481 | Pangea Femur Reconstruction System | June 29, 2026 |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | February 3, 2026 |
| K253202 | Hoffmann LRF System | December 19, 2025 |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | August 20, 2025 |
| K250163 | T2 Alpha Femur Retrograde Nailing System | August 13, 2025 |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating Sy | October 6, 2024 |
| K233919 | VariAx 2 Distal Radius System | March 25, 2024 |
| K233741 | Hoffmann LRF System | December 21, 2023 |
| K230045 | HipCheck | September 29, 2023 |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM | September 20, 2023 |
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humer | August 18, 2023 |
| K231257 | Pangea Utility Plating System, Pangea Platform | August 18, 2023 |
| K230512 | Gamma4 System | June 9, 2023 |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | May 19, 2023 |
| K222381 | PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | April 27, 2023 |
| K230754 | L12 LED Light Source with AIM | April 11, 2023 |
| K223772 | PRO Plating System, Stryker Trauma Pelvic Set (Matta) | April 7, 2023 |
| K230605 | 1788 4K Camera System with Advanced Imaging Modality | March 31, 2023 |
| K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) | February 23, 2023 |
| K222309 | Gamma4 System | November 15, 2022 |