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Smith & Nephew, Inc.

290 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 recall (Z-2456-2026)Smith & Nephew, Inc.2026-06-16
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. recall (Z-0957-2026)Smith & Nephew, Inc.2025-12-18
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 recall (Z-1806-2025)Smith & Nephew, Inc.2025-05-19
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. recall (Z-0581-2025)Smith & Nephew Inc.2024-11-29
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D recall (Z-0326-2025)Smith & Nephew, Inc.2024-11-07
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF recall (Z-0281-2025)Smith & Nephew Inc2024-10-31
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIG recall (Z-0282-2025)Smith & Nephew Inc2024-10-31
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 7142 recall (Z-0277-2025)Smith & Nephew Inc2024-10-30
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 7142 recall (Z-0278-2025)Smith & Nephew Inc2024-10-30
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener recall (Z-3171-2024)Smith & Nephew, Inc.2024-09-19
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener recall (Z-3172-2024)Smith & Nephew, Inc.2024-09-19
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic recall (Z-3096-2024)Smith & Nephew Inc.2024-09-10
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prostheti recall (Z-3097-2024)Smith & Nephew Inc.2024-09-10
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smi recall (Z-1901-2024)Smith & Nephew Inc2024-05-24
JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis recall (Z-0157-2024)Smith & Nephew, Inc.2023-10-24
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prost recall (Z-0158-2024)Smith & Nephew, Inc.2023-10-24
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT recall (Z-2621-2023)Smith & Nephew Inc2023-09-20
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur recall (Z-2443-2023)Smith & Nephew, Inc.2023-08-22
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur recall (Z-2444-2023)Smith & Nephew, Inc.2023-08-22
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Number recall (Z-1670-2023)Smith & Nephew, Inc.2023-05-31
Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) R recall (Z-1671-2023)Smith & Nephew, Inc.2023-05-31
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) R recall (Z-1672-2023)Smith & Nephew, Inc.2023-05-31
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) recall (Z-1673-2023)Smith & Nephew, Inc.2023-05-31
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM recall (Z-1393-2023)Smith & Nephew, Inc.2023-04-14
Tibial knee prosthesis recall (Z-2774-2020)Smith & Nephew, Inc.2020-08-08
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated f recall (Z-2702-2020)Smith & Nephew, Inc.2020-07-24
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 7 recall (Z-0001-2019)Smith & Nephew, Inc.2018-10-01
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112 recall (Z-0002-2019)Smith & Nephew, Inc.2018-10-01
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114 recall (Z-0003-2019)Smith & Nephew, Inc.2018-10-01
Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF recall (Z-2267-2018)Smith & Nephew, Inc.2018-05-21
Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) recall (Z-2268-2018)Smith & Nephew, Inc.2018-05-21
smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF recall (Z-1921-2018)Smith & Nephew, Inc.2018-05-09
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the dist recall (Z-1317-2018)Smith & Nephew, Inc.2018-03-20
Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based recall (Z-0409-2018)Smith & Nephew, Inc.2018-01-08
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) RE recall (Z-2624-2017)Smith & Nephew, Inc.2017-06-12
LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) RE recall (Z-2625-2017)Smith & Nephew, Inc.2017-06-12
PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, R recall (Z-2036-2017)Smith & Nephew, Inc.2017-04-14
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, s recall (Z-2297-2016)Smith & Nephew, Inc.2016-07-28
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 0 recall (Z-1537-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 0 recall (Z-1538-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 recall (Z-1539-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 recall (Z-1540-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 recall (Z-1541-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 recall (Z-1542-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 00 recall (Z-1543-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 0 recall (Z-1544-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 0 recall (Z-1545-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 0 recall (Z-1546-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 recall (Z-1547-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 recall (Z-1548-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 recall (Z-1549-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 00 recall (Z-1550-2016)Smith & Nephew, Inc.2016-04-21
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 00 recall (Z-1551-2016)Smith & Nephew, Inc.2016-04-21
Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDA recall (Z-0573-2016)Smith & Nephew, Inc.2016-01-04
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STE recall (Z-0372-2016)Smith & Nephew, Inc.2015-12-04
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, ST recall (Z-0373-2016)Smith & Nephew, Inc.2015-12-04
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbe recall (Z-2745-2015)Smith & Nephew, Inc.2015-09-10
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 741 recall (Z-2746-2015)Smith & Nephew, Inc.2015-09-10
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 7412 recall (Z-2747-2015)Smith & Nephew, Inc.2015-09-10
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal R recall (Z-1822-2015)Smith & Nephew, Inc.2015-06-22
R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Produ recall (Z-1735-2015)Smith & Nephew, Inc.2015-06-09
R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Produ recall (Z-1736-2015)Smith & Nephew, Inc.2015-06-09
R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Produ recall (Z-1737-2015)Smith & Nephew, Inc.2015-06-09
R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Produ recall (Z-1738-2015)Smith & Nephew, Inc.2015-06-09
R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO. Produ recall (Z-1739-2015)Smith & Nephew, Inc.2015-06-09
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & recall (Z-0589-2015)Smith & Nephew, Inc.2014-12-12
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & recall (Z-0590-2015)Smith & Nephew, Inc.2014-12-12
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & recall (Z-0591-2015)Smith & Nephew, Inc.2014-12-12
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and recall (Z-0039-2015)Smith & Nephew, Inc.2014-10-08
RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and recall (Z-0040-2015)Smith & Nephew, Inc.2014-10-08
RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENAS recall (Z-0041-2015)Smith & Nephew, Inc.2014-10-08
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who wou recall (Z-2688-2014)Smith & Nephew, Inc.2014-09-23
TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & recall (Z-2258-2014)Smith & Nephew, Inc.2014-08-17
TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 recall (Z-1636-2014)Smith & Nephew Inc2014-05-20
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676 recall (Z-1637-2014)Smith & Nephew Inc2014-05-20
Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are us recall (Z-1157-2014)Smith & Nephew Inc.2014-03-10
Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and recall (Z-1158-2014)Smith & Nephew Inc.2014-03-10
Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing recall (Z-1159-2014)Smith & Nephew Inc.2014-03-10
Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and recall (Z-1160-2014)Smith & Nephew Inc.2014-03-10
Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The recall (Z-1161-2014)Smith & Nephew Inc.2014-03-10
Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The REN recall (Z-1162-2014)Smith & Nephew Inc.2014-03-10
Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephe recall (Z-1066-2014)Smith & Nephew Inc2014-02-21
Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System recall (Z-1067-2014)Smith & Nephew Inc.2014-02-21
Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy Sys recall (Z-1068-2014)Smith & Nephew Inc.2014-02-21
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1 recall (Z-0581-2014)Smith & Nephew Inc2013-12-26
GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 714208 recall (Z-0444-2014)Smith & Nephew Inc2013-12-04
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, S recall (Z-0445-2014)Smith & Nephew Inc2013-12-04
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, ST recall (Z-0446-2014)Smith & Nephew Inc2013-12-04
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, ST recall (Z-0447-2014)Smith & Nephew Inc2013-12-04
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, S recall (Z-0448-2014)Smith & Nephew Inc2013-12-04
GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, recall (Z-0449-2014)Smith & Nephew Inc2013-12-04
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage recall (Z-0130-2014)Smith & Nephew Inc2013-11-01
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usag recall (Z-0131-2014)Smith & Nephew Inc2013-11-01
GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, recall (Z-1996-2013)Smith & Nephew Inc2013-08-22
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE recall (Z-1928-2013)Smith & Nephew Inc2013-08-08
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE recall (Z-1929-2013)Smith & Nephew Inc2013-08-08
TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smi recall (Z-1132-2013)Smith & Nephew Inc2013-04-17
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON S recall (Z-0943-2013)Smith & Nephew Inc2013-03-13
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON S recall (Z-0944-2013)Smith & Nephew Inc2013-03-13
12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ON recall (Z-2427-2012)Smith & Nephew Inc2012-09-20
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