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Smith & Nephew Recalls
258 recalls on record · September 26, 2012 to June 24, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 24, 2026Medical DevicesFDA
Smith & Nephew, Inc. recalls TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Hazard: 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.
December 24, 2025Medical DevicesFDA
Smith & Nephew, Inc. recalls BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Hazard: Removal of affected lot of screws due to labeling error.
May 28, 2025Medical DevicesFDA
Smith & Nephew, Inc. recalls META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Hazard: 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.
December 11, 2024Medical DevicesFDA
Smith & Nephew Inc. recalls BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Hazard: Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
November 13, 2024Medical DevicesFDA
Smith & Nephew, Inc. recalls Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femo
Hazard: The Bipolar assembly contains an oversized Retainer Ring.
November 6, 2024Medical DevicesFDA
Smith & Nephew Inc recalls smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Unco
Hazard: 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.
November 6, 2024Medical DevicesFDA
Smith & Nephew Inc recalls smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur
Hazard: 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.
November 6, 2024Medical DevicesFDA
Smith & Nephew Inc recalls smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELL
Hazard: 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.
November 6, 2024Medical DevicesFDA
Smith & Nephew Inc recalls smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELL
Hazard: 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.
September 25, 2024Medical DevicesFDA
Smith & Nephew, Inc. recalls DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
Hazard: 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.
September 25, 2024Medical DevicesFDA
Smith & Nephew, Inc. recalls DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
Hazard: 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.
September 18, 2024Medical DevicesFDA
Smith & Nephew Inc. recalls ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues.
Hazard: Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
September 18, 2024Medical DevicesFDA
Smith & Nephew Inc. recalls ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Pr
Hazard: Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
June 5, 2024Medical DevicesFDA
Smith & Nephew Inc recalls smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71
Hazard: Packaging contained the incorrect size of femoral head from what was displayed on the label.
November 1, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
Hazard: The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
November 1, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
Hazard: The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
September 27, 2023Medical DevicesFDA
Smith & Nephew Inc recalls smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee j
Hazard: The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
August 30, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
Hazard: A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
August 30, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Hazard: A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
June 7, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LE
Hazard: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
June 7, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT M
Hazard: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
June 7, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b
Hazard: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
June 7, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZ
Hazard: Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
April 26, 2023Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Hazard: A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
July 27, 2022Medical DevicesFDA
Smith & Nephew, Inc. recalls (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate
Hazard: The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
May 25, 2022Medical DevicesFDA
Smith & Nephew Inc recalls LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
Hazard: It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
February 16, 2022Medical DevicesFDA
Smith & Nephew, Inc. recalls Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open
Hazard: Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
February 9, 2022Medical DevicesFDA
Smith & Nephew, Inc. recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Hazard: The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
December 22, 2021Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
Hazard: Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
December 22, 2021Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
Hazard: Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.