Smith & Nephew, Inc.
258 recalls on record · Latest: Jun 24, 2026
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Agency notice ledger
Federal filing book Smith & Nephew, Inc. HEAVY-BOOK · SINGLE-AGENCY
#47 of 14,151 · 258 notices · 0.247% archive
- BOOK 258 notices
- RANK #47 of 14,151
- SHARE 0.247% archive
- AGENCY FDA Devices (258)
- CAT medical devices
- CATS 1 category
- LATEST Jun 24, 2026
- PHOTO Hospira Inc.
Nearest notice-volume peer: Hospira Inc. (1 notice gap)
Smith & Nephew, Inc. accounts for about 0.247% of the 104,423-notice archive on 258 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
Smith & Nephew, Inc.'s standing among 14,151 recalling firms
Smith & Nephew, Inc. ranks 47th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Smith & Nephew, Inc. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
258 47th of 14151 higher than 14,104 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Smith & Nephew, Inc. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- Hyundai
Hyundai
261 notices
- The Anspach E…
The Anspach Effort, Inc.
261 notices
- Smith & Nephe… (this)
Smith & Nephew, Inc.
258 notices
- Hospira Inc.
Hospira Inc.
257 notices
- Intuitive Sur…
Intuitive Surgical, Inc.
257 notices
- Biomet, Inc.
Biomet, Inc.
255 notices
What this shows Smith & Nephew, Inc. holds about 0.247% of archive notices alongside 258 distinct filings.
FDA Devices Moderate Jun 24, 2026
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
FDA Devices Moderate Dec 24, 2025
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
FDA Devices Moderate May 28, 2025
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
FDA Devices Moderate Dec 11, 2024
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
FDA Devices Moderate Nov 13, 2024
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
FDA Devices Moderate Nov 6, 2024
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
FDA Devices Moderate Nov 6, 2024
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
FDA Devices Moderate Nov 6, 2024
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
FDA Devices Moderate Nov 6, 2024
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
FDA Devices Moderate Sep 25, 2024
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
FDA Devices Moderate Sep 25, 2024
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
FDA Devices Moderate Sep 18, 2024
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
FDA Devices Moderate Sep 18, 2024
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
FDA Devices Moderate Jun 5, 2024
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
FDA Devices Moderate Nov 1, 2023
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
FDA Devices Moderate Nov 1, 2023
JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
FDA Devices Moderate Sep 27, 2023
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
FDA Devices Moderate Aug 30, 2023
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
FDA Devices Moderate Aug 30, 2023
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
FDA Devices Moderate Jun 7, 2023
Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis
FDA Devices Moderate Jun 7, 2023
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial); c) REF 1-10003-200 (SIZE 2-Right Medial); d) REF 1-10003-210 (SIZE 2-Left Medial); e) REF 1-10003-300 (SIZE 3- Right Medial); f) REF 1-10003-310 (SIZE 3- Left Medial); g) REF 1-10003-400 (SIZE 4- Right Medial); h) REF 1-10003-410 (SIZE 4- Left Medial); i) REF 1-10003-500 (SIZE 5- Right Medial); j) REF
FDA Devices Moderate Jun 7, 2023
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL; e) REF 1-10012-300, SIZE 3-LEFT MEDIAL; f) REF 1-10012-350, SIZE 3-RIGHT MEDIAL; g) REF 1-10012-400, SIZE 4-LEFT MEDIAL; h) REF 1-10012-450, SIZE 4-RIGHT MEDIAL; i) REF 1-10012-500, SIZE 5-LEFT MEDIAL; j) REF 1-10012-550, SIZE 5-RIGHT
FDA Devices Moderate Jun 7, 2023
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-10013-159, SIZE 1-RIGHT MED, 9MM; f) REF 1-10013-160, SIZE 1-RIGHT MED, 10MM; g) REF 1-10013-161, SIZE 1-RIGHT MED, 11MM; h) REF 1-10013-163, SIZE 1-RIGHT MED, 13MM; i) REF 1-10013-209, SIZE 2-LEFT MED, 9MM; j)
FDA Devices Moderate Apr 26, 2023
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
FDA Devices Moderate Jul 27, 2022
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
FDA Devices Moderate May 25, 2022
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
FDA Devices Moderate Feb 16, 2022
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
FDA Devices Moderate Feb 9, 2022
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
FDA Devices Moderate Dec 22, 2021
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
FDA Devices Moderate Dec 22, 2021
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
FDA Devices Moderate Dec 22, 2021
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
FDA Devices Moderate Dec 22, 2021
smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
FDA Devices Moderate Nov 24, 2021
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
FDA Devices Moderate Oct 27, 2021
6.5MMX165MM CANNULATED SCREW
FDA Devices Moderate Jun 30, 2021
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
FDA Devices Moderate May 5, 2021
CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208
FDA Devices Moderate Feb 10, 2021
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.
FDA Devices Moderate Jan 13, 2021
Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;
FDA Devices Moderate Nov 4, 2020
5.5MM Arthrogarde Hip Access Cannula
FDA Devices Moderate Oct 28, 2020
OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
FDA Devices Moderate Oct 28, 2020
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
FDA Devices Moderate Oct 28, 2020
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
FDA Devices Moderate Oct 28, 2020
TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
FDA Devices Moderate Oct 28, 2020
OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
FDA Devices Moderate Oct 28, 2020
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
FDA Devices Moderate Oct 28, 2020
MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
FDA Devices Moderate Oct 28, 2020
ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
FDA Devices Moderate Oct 28, 2020
OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
FDA Devices Moderate Oct 28, 2020
TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
FDA Devices Moderate Oct 28, 2020
OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
Smith & Nephew, Inc. carries an outsized archive share
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (258 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Smith & Nephew, Inc.? ▼
PlainRecalls indexes 258 distinct federal recall events naming Smith & Nephew, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Smith & Nephew, Inc. sit among other recalling firms? ▼
Smith & Nephew, Inc. ranks #47 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Smith & Nephew, Inc.'s notices? ▼
FDA Devices accounts for 258 of this firm's 258 indexed notices.
What product category dominates Smith & Nephew, Inc.'s filing book? ▼
Filings for Smith & Nephew, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Smith & Nephew, Inc.: 258 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Smith & Nephew, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026