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.

76–100 of 258

  • ModerateFDA (Devices)·Z-0155-2021·2020-10-28

    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 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0141-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX AB 5.0 Suture Anchors Due to Seal Defects

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

    Product
    TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0152-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Seal Issues

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

    Product
    OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0149-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling OSTEORAPTOR 2.3 suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2021·2020-10-28

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

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

    Product
    OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2945-2020·2020-09-16

    Smith & Nephew Recalls EVOS Screws Due to Incorrect Expiration Dates

    Smith & Nephew is recalling 71 units of EVOS Screws because the labels contain multiple or incorrect expiration dates.

    Product
    EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2818-2020·2020-08-26

    Smith & Nephew Recalls Single RIKKI Retractors Due to Improper Heat Treatment

    Smith & Nephew is recalling 111 units of Single RIKKI Retractors because they were improperly heat treated. The devices are used during surgery to hold soft tissue away from the surgical site.

    Product
    Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2777-2020·2020-08-19

    Smith & Nephew Recalls Misidentified PeriLoc Targeter Handle

    Smith & Nephew is recalling 3 units of a PeriLoc Targeter handle that was incorrectly marked as a left-hand part.

    Product
    PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2746-2020·2020-08-12

    Smith & Nephew Recalls SUTUREFIX ULTRA Suture Due to Packaging Error

    Smith & Nephew is recalling 868 units of SUTUREFIX ULTRA Suture because a packaging error caused an XL drill to be included instead of the correct S drill.

    Product
    SUTUREFIX ULTRA Suture, Product number 72203855
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2702-2020·2020-08-05

    Smith & Nephew T-F1X0 RCG Drill Pac Recalled for Missing Sleeve

    Smith & Nephew is recalling T-F1X0 RCG Drill Pacs because some sterile packages contain only one sleeve instead of two, preventing the device from performing as intended for the second bone tunnel.

    Product
    Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2685-2020·2020-07-29

    Smith & Nephew Recalls TRIGEN Intramedullary Nail Sleeves Due to Sterilization Error

    Smith & Nephew is recalling 12 TRIGEN intramedullary nail sleeves because a manufacturing error led to improper re-sterilization of the polyethylene material.

    Product
    TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2332-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 1,450 R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 7133
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2331-2020·2020-06-17

    Smith & Nephew R3 Acetabular Shells Recalled for Manufacturing Error

    Smith & Nephew is recalling R3 No Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2336-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 58 R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant co
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2334-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 4,172 R3 Acetabular Shells distributed worldwide because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 713
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2335-2020·2020-06-17

    Smith & Nephew Recalls R3 Multi Hole Hemispherical Shells Due to Manufacturing Error

    Smith & Nephew is recalling 1,766 R3 Multi Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2333-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60M
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2133-2020·2020-06-03

    Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments

    Smith & Nephew is recalling 195 reusable surgical instruments because a manufacturing defect could cause the device to disassemble during use.

    Product
    JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2020·2020-06-03

    Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments

    Smith & Nephew is recalling 200 units of Journey II Uni Resection Prep Trial instruments because a manufacturing defect could cause the device to disassemble during surgery.

    Product
    JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1756-2020·2020-04-29

    Smith & Nephew Recalls Footprint Ultra PK Suture Anchors Due to Sterile Breach Risk

    Smith & Nephew is recalling 125,196 Footprint Ultra PK Suture Anchors because packaging movement may displace the tip protector, creating a sterile breach.

    Product
    Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1757-2020·2020-04-29

    Smith & Nephew FOOTPRINT Ultra PK Suture Anchor Recall for Sterile Breach Risk

    Smith & Nephew is recalling FOOTPRINT Ultra PK Suture Anchors because excessive movement in packaging could displace the tip protector, potentially causing a sterile breach.

    Product
    Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2020·2020-04-08

    Smith & Nephew Recalls NAVIO Soft Tissue Protector Due to Binding Risk

    Smith & Nephew is recalling 348 NAVIO Soft Tissue Protectors because the instrument may become stuck to bone pins during surgery.

    Product
    NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected whe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1507-2020·2020-03-25

    Smith & Nephew Recalls Legion PS Knee Inserts Due to Packaging Error

    Smith & Nephew is recalling 29 Legion PS High Flex XLPE Articular Inserts because they were packaged with an incorrect part.

    Product
    LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1273-2020·2020-02-26

    Smith & Nephew Recalls TwinFix Ti Suture Anchors Due to Sterility Risk

    Smith & Nephew is recalling TwinFix Ti 2.8 mm HS Suture Anchors because a protective tube failure may have breached the sterile barrier.

    Product
    TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
    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.