The Recall Desk

Manufacturer

Smith & Nephew, Inc.

258 recalls in our database name Smith & Nephew, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
258
Critical
0
Severe
23
Most recent
2026-06-24

Of the 258 recalls from Smith & Nephew, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 23 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 258

  • HighFDA (Devices)·Z-1099-2022·2022-05-25

    Smith & Nephew knee implants recalled for labeling error

    Smith & Nephew is recalling knee implants shipped in incorrect packaging—a JOURNEY II femoral implant was boxed as a LEGION NARROW PS implant. The labeling error could result in the wrong implant being used during surgery.

    Product
    LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0635-2022·2022-02-16

    Acufex Access Advanced Positioning Kit Recalled for Missing Sterilization

    Smith & Nephew is recalling the Acufex Access Advanced Positioning Kit because the products were shipped to a distribution center instead of the sterilizer and were not sterilized before distribution.

    Product
    Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2022·2022-02-09

    INTEGRA SURFIX ALPHA Torx 10 Screwdriver Out of Specification Recalled

    Smith & Nephew recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10 units because they are out of specification and may not mate properly with the Surfix Alpha Lock screw.

    Product
    INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2022·2021-12-22

    EVOS Medial Distal Femur Plate IFU contains erroneous MRI scanning conditions

    Smith & Nephew recalled EVOS Medial Distal Femur Plates because the Instructions for Use contain erroneous MRI scanning data that was incorrectly incorporated from a vendor report.

    Product
    smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2022·2021-12-22

    Smith & Nephew EVOS Condylar Plate Recalled for Incorrect MRI Instructions

    Smith & Nephew is recalling 41 units of the EVOS Condylar Medial Distal Femur Plate due to erroneous MRI scanning conditions in the instructions for use.

    Product
    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2022·2021-12-22

    Smith & Nephew EVOS femur plates recalled for erroneous MRI instructions

    Smith & Nephew is recalling 38 EVOS femur plates because the product instructions contain erroneous MRI scanning conditions. The affected units were distributed nationwide across 14 states.

    Product
    smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2022·2021-12-22

    Orthopedic Femur Plate Recalled for Incorrect MRI Safety Information

    Smith & Nephew is recalling 35 units of EVOS Condylar Medial Distal Femur Plate due to incorrect MRI scanning safety information in the product instructions. The instructions contained erroneous data that could affect patient safety during MRI procedures.

    Product
    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2022·2021-11-24

    Smith & Nephew EVOS Self-Tapping Locking Screws recalled due to switched package labels

    Smith & Nephew is recalling 224 units of EVOS Self-Tapping Locking Screws because package labels were switched, creating a risk that incorrect screw sizes could be implanted during surgery.

    Product
    Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-0143-2022·2021-10-27

    Smith & Nephew cannulated screw label incorrectly indicates threading type

    Smith & Nephew is recalling 6.5mm x 165mm cannulated screws because the product label incorrectly states the screws are fully threaded when they are actually partially threaded.

    Product
    6.5MMX165MM CANNULATED SCREW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2021·2021-06-30

    LEGION Knee Prosthesis Component Recalled for Manufacturing Surface Damage

    Smith & Nephew is recalling 5 units of a knee prosthesis component due to surface damage from a manufacturing error. The affected lot was distributed in specific U.S. states.

    Product
    LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1510-2021·2021-05-05

    Smith & Nephew Recalls Mislabeled CANNU-Flex SILK Interference Screws

    Smith & Nephew is recalling CANNU-Flex SILK Interference Screws because some boxes were mislabeled, containing 6mm x 20mm screws instead of the labeled 6mm x 30mm size.

    Product
    CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0933-2021·2021-02-10

    Smith & Nephew Recalls Versabond AB Bone Cement Due to Heat Exposure

    Smith & Nephew is recalling 5,190 units of Versabond AB bone cement due to potential heat and humidity exposure that altered the product's consistency.

    Product
    VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0772-2021·2021-01-13

    Smith & Nephew Recalls Trigen Intertan Bone Fixation Nails for Packaging Error

    Smith & Nephew is recalling 41 units of Trigen Intertan bone fixation nails due to a manufacturing packaging error. The devices were distributed nationwide and in Australia, Canada, and the UK.

    Product
    Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2021·2020-11-04

    Smith & Nephew Recalls 5.5MM Arthrogarde Hip Access Cannula

    Smith & Nephew is recalling 143 units of 5.5MM Arthrogarde Hip Access Cannulas because the J Lock feature was manufactured incorrectly, preventing proper locking into irrigation extenders or arthroscopes.

    Product
    5.5MM Arthrogarde Hip Access Cannula
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-0118-2021·2020-10-28

    Smith & Nephew Recalls Genesis Knee Implants Due to Design Defect

    Smith & Nephew is recalling 47 Genesis knee implants because the anterior locking detail does not meet design specifications.

    Product
    Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2021·2020-10-28

    Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors

    Smith & Nephew is recalling Ultra Fast-Fix AB Assembly suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0162-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors

    Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2021·2020-10-28

    Smith & Nephew Recalls Healicoil Suture Anchors Due to Packaging Seal Issues

    Smith & Nephew is recalling Healicoil absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Packaging Seal Issues

    Smith & Nephew is recalling TWINFIX 6.5mm suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0136-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling TWINFIX 5.0mm suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2021·2020-10-28

    Smith & Nephew Recalls Microraptor Regenesorb Suture Anchors for Seal Issues

    Smith & Nephew is recalling Microraptor Regenesorb Suture Anchors because improper or incomplete pouch seals may breach the sterile barrier.

    Product
    MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling TWINFIX 6.5mm absorbable suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0137-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling TWINFIX 5.0mm AB Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2021·2020-10-28

    Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Smith & Nephew

a company producing medical equipment

Country
United Kingdom
Founded
1856

Official website

Source: Wikidata (Q502509), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.