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Smith & Nephew, Inc. FDA Recalls
36 recalls on file across devices, 0 of them Class I and 27 still open. Matched by name to SNN.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816Class IIMar 16, 2026Humeral nail due to a manufacturing error is missing distal |
| BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.Class IINov 24, 2025Removal of affected lot of screws due to labeling error. |
| META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690Class IIMar 18, 2025Integrated Lag/Compression Screw Kit has a compression screw |
| BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.Class IIOct 29, 2024Sterile barrier breach due to inadequate packaging design th |
| Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoClass IIOct 15, 2024The Bipolar assembly contains an oversized Retainer Ring. |
| smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLClass IIOct 2, 2024Complaint received indicating that a package contained a LGN |
| smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femurClass IIOct 2, 2024Complaint received indicating that a package contained a LEG |
| smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; UncoClass IIOct 2, 2024Complaint received indicating that a package contained a LEG |
| smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLClass IIOct 2, 2024Complaint received indicating that a package contained a LGN |
| ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. PrClass IIAug 12, 2024Product packaging process may result in an improper or incom |
| ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Class IIAug 12, 2024Product packaging process may result in an improper or incom |
| DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastenerClass IIJul 9, 2024Smith & Nephew, Inc., has initiated a field action to volunt |
| DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastenerClass IIJul 9, 2024Smith & Nephew, Inc., has initiated a field action to volunt |
| smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71Class IIApr 24, 2024Packaging contained the incorrect size of femoral head from |
| JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesisClass IISep 27, 2023The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etche |
| JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesisClass IISep 27, 2023The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etche |
| smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee jClass IIAug 31, 2023The firm conducting a recall due to a complaint received ind |
| TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nailClass IIJul 24, 2023A complaint was received indicating that a package contained |
| TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nailClass IIJul 24, 2023A complaint was received indicating that a package contained |
| Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZClass IIMay 2, 2023Recent complaint data indicates that the revision rate may b |
| Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEClass IIMay 2, 2023Recent complaint data indicates that the revision rate may b |
| Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), bClass IIMay 2, 2023Recent complaint data indicates that the revision rate may b |
| Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MClass IIMay 2, 2023Recent complaint data indicates that the revision rate may b |
| JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MMClass IIMar 27, 2023A mispack occurred during the manufacturing process, resulti |
| (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Class IIJun 27, 2022The product was mispackaged (swapped). The devices within t |
| LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5Class IIApr 19, 2022It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 wa |
| INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 NDClass IIJan 4, 2022The affected screwdrivers are out of specification and may n |
| Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during openClass IIDec 14, 2021Products were shipped to the Global Distribution Center inst |
| smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202Class IINov 1, 2021Testing vendor notified Smith & Nephew that previous MRI sca |
| smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101Class IINov 1, 2021Testing vendor notified Smith & Nephew that previous MRI sca |
| smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102Class IINov 1, 2021Testing vendor notified Smith & Nephew that previous MRI sca |
| smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201Class IINov 1, 2021Testing vendor notified Smith & Nephew that previous MRI sca |
| Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MMClass IIOct 25, 2021The labels on the packages of screws were switched. |
| 6.5MMX165MM CANNULATED SCREWClass IISep 20, 2021The product label incorrectly indicated that the screws are |
| LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5Class IIMay 19, 2021The device components experienced a manufacturing process er |
| CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of sClass IIApr 8, 2021Mislabeled box contained a 6mm x 20mm screw instead of 6mm |