Smith & Nephew, Inc.
Smith & Nephew, Inc. holds FDA 510(k) medical device clearances, first cleared 1980, most recent 2026, with 257 FDA device recalls on record.
Name variants for Smith & Nephew, Inc.
as filed with FDA- Smith & Nephew, Inc.
- Smith+Nephew, Inc.
Top product codes for Smith & Nephew, Inc.
FDA recalls by Smith & Nephew, Inc.
10 most recent of 257- Z-0957-2026 — BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
- Z-1806-2025 — META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
- Z-0581-2025 — BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
- Z-0326-2025 — Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
- Z-0281-2025 — smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
- Z-0277-2025 — smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
- Z-0278-2025 — smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
- Z-0282-2025 — smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
- Z-3097-2024 — ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
- Z-3096-2024 — ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
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 Smith & Nephew, Inc.
1–100 of 533- K261462 — LANDMARK Total Knee System
- K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more
- DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
- K252129 — AETOS Shoulder System Stemless Humeral Prosthesis
- K251627 — BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue) +4 more
- K243608 — TRIGEN Stable Lock Nut & Washer
- K250677 — LEGION Total Knee System
- K250571 — CATALYSTEM Femoral Stems
- K243364 — TRIGEN META-TAN Trochanteric Antegrade Nail
- K240716 — AETOS Shoulder System Stemless Humeral Prosthesis
- K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
- K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
- K242375 — OR3O Dual Mobility System
- K240061 — TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System
- K241804 — TRIGEN INTERTAN 10S Nail System
- K240381 — CATALYSTEM Femoral Stems
- K241435 — Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue +3 more
- K240113 — CORIOGRAPH Knee Pre-Op Plan
- K233949 — ACCORD Cable System
- K233396 — Cannulated Screw System
- K232667 — OR3O Dual Mobility Liners
- K231376 — Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)
- K232005 — HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue) +1 more
- K231448 — TANDEM Hip System
- K230761 — TRIGEN META-NAIL Nail System
- K230572 — AETOS Shoulder System
- K230653 — Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates
- K230555 — Cemented Tibia Baseplate no Taper with JRNY Lock
- K222971 — ULTRABUTTON QUAD Adjustable Fixation Device +4 more
- K220847 — AETOS Shoulder System
- K223112 — MAVERICK Mini External Fixation System
- K210980 — Smith & Nephew Intramedullary Nail Systems
- K222653 — JOURNEY II UK and ENGAGE Cementless Partial Knee System
- K213123 — EVOS Wrist Spanning Plate
- K213126 — Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws
- K221792 — Acute QC Strut and Components
- K220959 — OR3O Dual Mobility System
- K221939 — Cemented Round Patella with JRNY Pegs
- K211176 — Smith & Nephew Hip Systems
- K220896 — Legion Inserts with JRNY Lock
- K213827 — TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)
- K213874 — MAVERICK External Fixation System
- K211330 — R3 Large Head Liners
- K211221 — Porous Patella and Porous Tibia Baseplate
- K211512 — VISIONAIRE UK Patient Matched Cutting Guides
- K211671 — Journey II Mid-Level Tibial Inserts
- K210953 — SMART Taylor Spatial Frame
- K203175 — POLARSTEM Cemented Femoral Stem
- K211548 — POLARSTEM Calcar Reamer Guide
- K210837 — Smith & Nephew Plates and Screws
- K211246 — LEGION CR Porous Plus HA Femoral Components
- K210784 — Extended HA Half Pins
- K210566 — LEGION Porous CR Narrow Femoral Components
- K203393 — FAST-FIX FLEX
- K203405 — EVOS Large Fragment Plating System
- K201918 — EVOS Large Fragment Plating System
- K202762 — Circular Fixation with Balanced Cable Transport
- K201701 — R3 HA Coated Acetabular Shells
- K201527 — EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
- K200227 — Journey II XR Knee Instrument
- K200826 — Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
- K193558 — HEALICOIL Knotless Suture Anchors
- K200407 — LEGION Inserts with JRNY Lock
- K193029 — CONQUEST FN
- K191002 — OR3O Dual Mobility System
- K190847 — REDAPT Blade Augments
- K192155 — Smith & Nephew DYONICS 25 Fluid Management System
- K191211 — JOURNEY II Unicompartmental Knee System
- K190253 — EVOS Small Fragment Upper Extremity Plates Line Additions
- K190085 — Journey II Unicompartmental Knee System
- K183010 — Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
- K182535 — R3 Anteverted Liners
- K182109 — REDAPT Modular Acetabular Shell
- K181366 — REDAPT Porous Acetabular Shell
- K181533 — EVOS Wrist Fracture Plating System
- K180277 — Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
- K180334 — LEGION Knee System
- K172336 — Smith & Nephew Patient Matched Cutting Blocks
- K173293 — EVOS Small Fragment Upper Extremity Plates
- K171934 — Birmingham Hip (BH) Dual Mobility Insert
- K171073 — Smith & Nephew, Inc. REDAPT Augments
- K173331 — JOURNEY II XR Knee Instruments
- K172684 — Smith & Nephew, Inc. ANTHOLOGY AFIT Hip Stem
- K172262 — EVOS Small Fragment Plating System
- K171794 — Smith & Nephew 25 Fluid Management System
- K162641 — Smith & Nephew, Inc. R3 Constrained Liner
- K170457 — EVOS Small Fragment Lower Extremity Plates
- K162996 — INVISIKNOT Ankle Syndesmosis Repair Kit
- K170282 — Smith & Nephew VISIONAIRE Adaptive Guides
- K170648 — ANTHEM CR Total Knee System
- K170977 — SURESHOT Distal Targeting System V4.0 Trauma Interface
- K162303 — REDAPT Sleeved Monolithic Revision Stems
- K170280 — Smith & Nephew SURESHOT Distal Targeting System V4.0
- K170887 — EVOS Small Fragment Plating System
- K162775 — Legion Cone System
- K163086 — VLP MINI-MOD 2.0mm Column Plates
- K161233 — OXINIUM DH Fermoral Heads
- K161264 — TRIGEN Low Profile Bone Screws
Data sourced from openFDA. This site is unofficial and independent of the FDA.