Smith & Nephew, Inc.
FDA adverse event reports naming Smith & Nephew, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SMITH & NEPHEW, INC..
- Total reports
- 83,585
- Deaths
- 41
- Injuries
- 31,288
- Malfunctions
- 52,162
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH12,919
- Suture, Nonabsorbable, Synthetic, PolyethyleneGAT12,295
- Saw, Powered, And AccessoriesHAB8,783
- Fastener, Fixation, Nondegradable, Soft TissueMBI5,401
- Prosthesis, Hip, Femoral Component, Cemented, MetalJDG4,064
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY3,218
- Orthopedic Manual Surgical InstrumentLXH3,149
- Rod, Fixation, Intramedullary And AccessoriesHSB2,481
- Fastener, Fixation, Biodegradable, Soft TissueMAI2,199
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2,198
Recent recalls
- 2026-06-16Open, ClassifiedProcess control
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.
- 2025-12-18Open, ClassifiedPackaging process control
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Removal of affected lot of screws due to labeling error.
- 2025-05-19Open, ClassifiedProcess control
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
- 2024-11-29Open, ClassifiedPackage design/selection
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
- 2024-11-07Open, ClassifiedUnder Investigation by firm
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.
The Bipolar assembly contains an oversized Retainer Ring.
- 2024-10-31Open, ClassifiedPackaging change control
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
- 2024-10-31Open, ClassifiedPackaging change control
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
- 2024-10-30Open, ClassifiedPackaging change control
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
- 2024-10-30Open, ClassifiedPackaging change control
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
- 2024-09-19Open, ClassifiedPackaging change control
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
Monitor Smith & Nephew, Inc. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.