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.

101–125 of 258

  • ModerateFDA (Devices)·Z-0878-2020·2020-02-05

    Smith & Nephew Recalls Legion AP Cutting Blocks Due to Design Defect

    Smith & Nephew is recalling specific lots of LEGION AP Cutting Blocks because they were manufactured with an oversize green plunger hole, failing to meet design specifications.

    Product
    LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0696-2020·2019-12-25

    Smith & Nephew Recalls PROFIX Mallets Due to Tip Detachment Risk

    Smith & Nephew is recalling 1,371 PROFIX Mallets because the poly tip may detach during surgery, potentially releasing particles into the surgical field.

    Product
    smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0351-2020·2019-11-20

    Smith & Nephew Recalls LAG Screw Guide Pin Sleeves Due to Manufacturing Error

    Smith & Nephew is recalling 116 LAG Screw 3.2mm Guide Pin Sleeves because a manufacturing error prevented the detent balls from fully compressing.

    Product
    LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2538-2019·2019-09-18

    Smith & Nephew Recalls Legion Hemi Step Tibial Wedge Due to Packaging Error

    Smith & Nephew is recalling 12 units of Legion Hemi Step Tibial Wedges because they were inadvertently packaged with an incorrect screw component.

    Product
    LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1042-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1044-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1045-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 46 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1043-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1028-2019·2019-03-27

    Smith & Nephew Recalls Mislabelled Hip Stem Implants Due to Size Error

    Smith & Nephew is recalling 58 hip stem implants because the outer label incorrectly identified the product as size "1" instead of "-1".

    Product
    smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1029-2019·2019-03-27

    Smith & Nephew Recalls Mislabelled High Offset StikTite Coated Hip Stems

    Smith & Nephew is recalling 9 units of hip stems where the outer label incorrectly identified the product as size "1" instead of the actual size "-1".

    Product
    smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0730-2019·2019-01-23

    Smith & Nephew Recalls SL Plus Mia Double Offset Adapter Units

    Smith & Nephew is recalling 72 units of the SL Plus Mia Double Offset Adapter because a pin may not be properly mounted and could disassemble.

    Product
    SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0200-2019·2018-10-31

    Smith+Nephew Legion AP Femoral Cutting Block Recalled for Oversized Spring

    Smith & Nephew is recalling one lot of Legion AP femoral cutting blocks, size 6, because they were manufactured with an oversized spring.

    Product
    Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0001-2019·2018-10-10

    Smith & Nephew Recalls Journey BCS Knee CoCr Femoral Components

    Smith & Nephew is recalling Journey BCS Knee CoCr Femoral Components because registry data indicates the first-generation system has a revision rate over 1.5 times the class average.

    Product
    Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0002-2019·2018-10-10

    Smith & Nephew Recalls Journey BCS Oxinium Knee Femoral Components

    Smith & Nephew is recalling Journey BCS Oxinium knee femoral components due to elevated revision rates reported in international joint registries.

    Product
    JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 7402113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2019·2018-10-10

    Smith & Nephew Recalls JOURNEY BCS Knee Polyethylene Inserts

    Smith & Nephew is recalling JOURNEY BCS Knee Conventional Polyethylene Inserts due to elevated revision rates reported in international joint registries.

    Product
    JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 7402313
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2883-2018·2018-08-29

    Smith & Nephew Recalls Mispackaged Genesis II Knee Prosthesis Components

    Smith & Nephew is recalling two lots of Genesis II knee prosthesis components because they were packaged with the wrong size and side.

    Product
    GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2268-2018·2018-06-27

    Smith & Nephew Recalls Birmingham Hip Resurfacing Acetabular Cups for Labeling Defects

    Smith & Nephew is recalling six Birmingham Hip Resurfacing Acetabular Cups because they were distributed in the US with international labeling instead of FDA-approved instructions.

    Product
    Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62 mm, REF 74122162
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2163-2018·2018-06-20

    Smith & Nephew Recalls GENESIS II Tibial Punches Due to Size Defect

    Smith & Nephew is recalling 5 units of GENESIS II 13 mm tibial punches because they are 2 mm smaller than the specified size.

    Product
    smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1921-2018·2018-05-30

    Smith & Nephew Recalls Anthology Hip Stems Due to Manufacturing Defect

    Smith & Nephew is recalling 13 units of Anthology hip prosthesis stems because they were manufactured with an undersized taper length.

    Product
    smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2018·2018-05-30

    Smith & Nephew Recalls Genesis II Knee Bushings Due to Labeling Error

    Smith & Nephew is recalling 18 units of Genesis II knee bushings because the left and right sides were incorrectly laser marked.

    Product
    smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activ
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1904-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 16 units of Legion CR XLPE Articular Inserts because the inner packaging pouch was inadvertently sealed with the outer pouch.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1907-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 47 units of Legion CR XLPE Articular Inserts due to a packaging error where inner and outer pouches were sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1905-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 72 units of Legion CR XLPE Articular Inserts because the inner and outer packaging pouches were inadvertently sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1906-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling Legion CR XLPE High Lexion Articular Inserts due to a packaging error where inner and outer pouches were sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states

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.