Smith & Nephew, Inc.: Medical Device Recalls in 2020
Updated on March 25, 2026.
According to to data from the FDA, there were 63 medical device recalls made by Smith & Nephew, Inc. in 2020. See the details of the recalls below.
You can see similar recalls for other firms.
Data Source: FDA.
- TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
- 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.
- SUTUREFIX ULTRA Suture, Product number 72203855
- 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).
- 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 71332262 64MM 71332264 Orthopedic implant component.
- 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 71331962 64MM 71331964 68MM 71331968 Orthopedic implant component.
- Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
- 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 spikes (spike rail) aids in provisional fixation of the trial. SIZE 1, CATALOG NUMBER: REF 74035831 SIZE 2, CATALOG NUMBER: REF 74035832 SIZE 3, CATALOG NUMBER: REF 74035833 SIZE 4, CATALOG NUMBER: REF 74035834 SIZE 5, CATALOG NUMBER: REF 74035835 SIZE 6, CATALOG NUMBER: REF 74035836 SIZE 7, CATALOG NUMBER: REF 74035837 SIZE 8, CATALOG NUMBER: REF 74035838 SIZE 9, CATALOG NUMBER: REF 74035839 SIZE 10, CATALOG NUMBER: REF 74035840
- 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 component.
- Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
- 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 tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.
- 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 spikes (spike rail) aids in provisional fixation of the trial. SIZE 1, CATALOG NUMBER: REF 74035821 SIZE 2, CATALOG NUMBER: REF 74035822 SIZE 3, CATALOG NUMBER: REF 74035823 SIZE 4, CATALOG NUMBER: REF 74035824 SIZE 5, CATALOG NUMBER: REF 74035825 SIZE 6, CATALOG NUMBER: REF 74035826 SIZE 7, CATALOG NUMBER: REF 74035827 SIZE 8, CATALOG NUMBER: REF 74035828 SIZE 9, CATALOG NUMBER: REF 74035829 SIZE 10, CATALOG NUMBER: REF 74035830
- Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
- TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
- HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
- ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
- BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
- HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
- TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
- TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
- TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
- OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
- TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
- TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
- MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
- 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.
- OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
- HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
- RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
- HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
- 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.
- TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
- 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 60MM 71335560 Orthopedic implant component.
- OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
- OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
- MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
- TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
- OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
- TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
- 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
- HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
- OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
- ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
- 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.
- 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.
- TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
- TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
- OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
- OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
- ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
- Tibial knee prosthesis
- OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
- TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
- TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
- TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
- HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
- TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
- TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
- TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
- HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
- 5.5MM Arthrogarde Hip Access Cannula
- 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 when placing the bone pins.
- LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
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