Smith & Nephew, Inc.

FDA Regulatory Profile

Summary

Total Recalls
257
510(k) Clearances
551
Inspections
31
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-0957-2026Class IIBIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.November 24, 2025
Z-1806-2025Class IIMETA-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690March 18, 2025
Z-0581-2025Class IIBIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.October 29, 2024
Z-0326-2025Class IITandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 713October 15, 2024
Z-0282-2025Class IIsmith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROWOctober 2, 2024
Z-0277-2025Class IIsmith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSOctober 2, 2024
Z-0281-2025Class IIsmith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015;October 2, 2024
Z-0278-2025Class IIsmith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSOctober 2, 2024
Z-3097-2024Class IIROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic materiaAugust 12, 2024
Z-3096-2024Class IIROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material August 12, 2024
Z-3172-2024Class IIDIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastenerJuly 9, 2024
Z-3171-2024Class IIDIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastenerJuly 9, 2024
Z-1901-2024Class IIsmith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew,April 24, 2024
Z-0157-2024Class IIJOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesisSeptember 27, 2023
Z-0158-2024Class IIJOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesisSeptember 27, 2023
Z-2621-2023Class IIsmith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, August 31, 2023
Z-2443-2023Class IITRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nailJuly 24, 2023
Z-2444-2023Class IITRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nailJuly 24, 2023
Z-1671-2023Class IISmith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-100May 2, 2023
Z-1672-2023Class IISmith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-1001May 2, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0October 29, 2025
K252129AETOS Shoulder System Stemless Humeral ProsthesisOctober 3, 2025
K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture AncJune 25, 2025
K243608TRIGEN Stable Lock Nut & WasherJune 12, 2025
K250677LEGION Total Knee SystemApril 2, 2025
K250571CATALYSTEM Femoral StemsMarch 28, 2025
K241666EVOS Pelvic and Acetabular SystemFebruary 19, 2025
K243364TRIGEN META-TAN Trochanteric Antegrade NailDecember 9, 2024
K240716AETOS Shoulder System Stemless Humeral ProsthesisNovember 20, 2024
K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)October 30, 2024
K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; SynergOctober 21, 2024
K242375OR3O Dual Mobility SystemOctober 7, 2024
K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSeptember 20, 2024
K240487EVOS Patella PlatesSeptember 3, 2024
K241804TRIGEN INTERTAN 10S Nail SystemAugust 22, 2024
K240381CATALYSTEM Femoral StemsJune 27, 2024
K241435Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-SuturJune 20, 2024
K240113CORIOGRAPH Knee Pre-Op PlanMarch 18, 2024
K233949ACCORD Cable SystemMarch 13, 2024
K233730Footprint Mini PK, 3.5mm Suture AnchorJanuary 17, 2024