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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 17, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product n
Hazard: A manufacturing error resulted in out of specification R3 Acetabular Shells
June 17, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/
Hazard: A manufacturing error resulted in out of specification R3 Acetabular Shells
June 17, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product numb
Hazard: A manufacturing error resulted in out of specification R3 Acetabular Shells
June 3, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial
Hazard: The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
June 3, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial
Hazard: The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
April 29, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
Hazard: Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create a sterile breach.
April 29, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
Hazard: Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.
April 8, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument design
Hazard: Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
March 25, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Hazard: LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
February 26, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tiss
Hazard: Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.
February 5, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Si
Hazard: Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
December 25, 2019Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument
Hazard: There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.
November 20, 2019Medical DevicesFDA
Smith & Nephew, Inc. recalls LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of
Hazard: LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress.
September 18, 2019Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained
Hazard: The affected products were inadvertently packaged with an incorrect screw component.
April 3, 2019Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a re
Hazard: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
April 3, 2019Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a re
Hazard: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
April 3, 2019Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a re
Hazard: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
April 3, 2019Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a re
Hazard: Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
March 27, 2019Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
Hazard: Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
March 27, 2019Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Hazard: Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
January 23, 2019Medical DevicesFDA
Smith & Nephew, Inc. recalls SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
Hazard: The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.
October 31, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femor
Hazard: One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
October 10, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 7402311
Hazard: The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.
October 10, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 7402111
Hazard: The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.
October 10, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215,
Hazard: The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.
August 29, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Hazard: Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
June 27, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c
Hazard: The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
June 27, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
Hazard: The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
June 20, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Hazard: One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
May 30, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
Hazard: Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.