Stryker GmbH
Stryker GmbH holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2026, with 75 FDA device recalls on record.
Top product codes for Stryker GmbH
FDA recalls by Stryker GmbH
10 most recent of 75- Z-2828-2026 — Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
- Z-2831-2026 — Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.
- Z-2827-2026 — Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
- Z-2832-2026 — Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
- Z-2833-2026 — Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
- Z-2829-2026 — Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
- Z-2830-2026 — Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
- Z-1914-2025 — Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
- Z-1939-2025 — Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
- Z-1940-2025 — Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Stryker GmbH
- K261481 — Pangea Femur Reconstruction System
- K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
- K253202 — Hoffmann LRF System
- K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
- K250163 — T2 Alpha Femur Retrograde Nailing System
- K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
- K233919 — VariAx 2 Distal Radius System
- K233741 — Hoffmann LRF System
- K231257 — Pangea Utility Plating System, Pangea Platform
- K231262 — Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
- K230512 — Gamma4 System
- K222381 — PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
- K223772 — PRO Plating System, Stryker Trauma Pelvic Set (Matta)
- K222309 — Gamma4 System
- K221346 — Stryker VariAx 2 MIS Calcaneus
- K210582 — EasyClip® and EasyClip® Xpress
- K220319 — Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
- K213328 — Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
- K212581 — VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
- K213199 — Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System
- K211508 — Steinmann Pins and Kirschner Wires
- K210861 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K203819 — T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System
- K203568 — Hoffmann LRF System
- K202749 — ADAPT for Gamma3
- K202289 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K201715 — Smart Toe II, X Fuse
- K200880 — T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System
- K200398 — AxSOS 3 AF System and AxSOS 3 Ti System
- K193366 — T2 ICF
- K192675 — VariAx Foot
- K191412 — VariAx 2 System, VariAx 2 Mini Fragment System
- K183104 — Mini Cannulated Headed and Headless Screw Set
- K183039 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K182968 — Hoffmann LRF System
- K181848 — ADAPT for Gamma3, Gamma3
- K181091 — AxSOS 3 Ti
- K181742 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K180500 — VariAx 2 System
- K173946 — ADAPT for Gamma3
- K172148 — Anchorage Bone Plating System
- K172350 — AxSOS 3 Ti
- K173135 — VariAx 2 System
- K170727 — VariAx 2 Compression Plating System
- K170771 — VariAx 2 Foot System
- K163656 — Hoffmann LRF System
- K162841 — VariAx Distal Radius Plating System, VariAx 2 System
- K162439 — AxSOS 3 Ti; Stryker Plating System
- K161863 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
- K161753 — Hoffman LRF System
- K160813 — EasyStep
- K153379 — AxSOS 3Ti
- K153377 — Hoffmann LRF (Limb Reconstruction Frame) System
- K151769 — Anchorage 2 CP System
- K151879 — VariAx 2 One-Third Tubular Plating System
Data sourced from openFDA. This site is unofficial and independent of the FDA.