--- title: "Smith & Nephew, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Smith & Nephew, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/smith-nephew-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Smith & Nephew, Inc. recall records **27** reported ongoing 33 records in this archive. Latest source date Mar 16, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Mar 16, 2026 FDA device enforcement ### [TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816](https://isitonrecall.com/recall/fda-device-z-2456-2026-trigen-proximal-straight-humeral-nail-8-7-x-16-ref-71760816/) Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would requ... Class II Reported ongoing Distribution: International distribution to the countries of BE, DE, IT. [Official source for TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2456-2026%22) Nov 24, 2025 FDA device enforcement ### [BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.](https://isitonrecall.com/recall/fda-device-z-0957-2026-biosure-ha-screw-6mm-x-20-mm-threaded-metallic-bone-fixation-fastener/) Removal of affected lot of screws due to labeling error. Class II Reported ongoing Distribution: US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN, NC, NE, NY, OK, TN, TX, UT; OUS (Foreign) to countries of: Australia, Czech Republic, Finland, France... [Official source for BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0957-2026%22) Mar 18, 2025 FDA device enforcement ### [META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690](https://isitonrecall.com/recall/fda-device-z-1806-2025-meta-tan-lag-compression-screw-kit-90mm-85mm-ref-71642690/) Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA. [Official source for META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1806-2025%22) Oct 29, 2024 FDA device enforcement ### [BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.](https://isitonrecall.com/recall/fda-device-z-0581-2025-bioraptor-suture-anchors-tendon-ligament-non-bioabsorbable-bone-anchor/) Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR. [Official source for BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0581-2025%22) Oct 15, 2024 FDA device enforcement ### [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.](https://isitonrecall.com/recall/fda-device-z-0326-2025-tandem-intl-bipolar-cocr-shell-uhmwpe-liner-ti-6al-4v-retaining-ring-28mm-i-d-46-mm-o-d-ref-71324046/) The Bipolar assembly contains an oversized Retainer Ring. Class II Reported ongoing Distribution: International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey. [Official source for Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0326-2025%22) Oct 2, 2024 FDA device enforcement ### [smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/...](https://isitonrecall.com/recall/fda-device-z-0277-2025-smith-nephew-leigon-oxinium-constrained-nonporous-femoral-component-size-3-left-ref-71421163-prosthe/) Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label. Class II Reported ongoing Distribution: US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,. [Official source for smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; P...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0277-2025%22) Oct 2, 2024 FDA device enforcement ### [smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/...](https://isitonrecall.com/recall/fda-device-z-0278-2025-smith-nephew-leigon-oxinium-constrained-nonporous-femoral-component-size-4-left-ref-71421164-prosthe/) Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label. Class II Reported ongoing Distribution: US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,. [Official source for smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; P...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0278-2025%22) Oct 2, 2024 FDA device enforcement ### [smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic](https://isitonrecall.com/recall/fda-device-z-0281-2025-smith-nephew-genesis-ii-nonporous-posterior-stabilized-femoral-component-size-5-left-ref-71421015-un/) Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label. Class II Reported ongoing Distribution: US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada [Official source for smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 714210...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0281-2025%22) Oct 2, 2024 FDA device enforcement ### [smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic](https://isitonrecall.com/recall/fda-device-z-0282-2025-smith-nephew-legion-oxinium-posterior-stabilized-nonporous-femoral-component-size-5n-right-narrow-re/) Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label. Class II Reported ongoing Distribution: US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada [Official source for smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NAR...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0282-2025%22) Aug 12, 2024 FDA device enforcement ### [ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1](https://isitonrecall.com/recall/fda-device-z-3096-2024-rotation-medical-tendon-staples-8-broad-indication-intended-for-fixation-of-prosthetic-material-to-s/) Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lit... [Official source for ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic materi...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3096-2024%22) Aug 12, 2024 FDA device enforcement ### [ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201](https://isitonrecall.com/recall/fda-device-z-3097-2024-rotation-medical-tendon-staples-8-narrow-indication-intended-for-fixation-of-prosthetic-material-to/) Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lit... [Official source for ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic mater...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3097-2024%22) Jul 9, 2024 FDA device enforcement ### [DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener](https://isitonrecall.com/recall/fda-device-z-3171-2024-diamond-point-both-ends-k-wire-ref-128042-metallic-bone-fixation-fastener/) Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on... Class II Reported ongoing Distribution: US, Canada, Norway [Official source for DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3171-2024%22) Jul 9, 2024 FDA device enforcement ### [DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener](https://isitonrecall.com/recall/fda-device-z-3172-2024-diamond-point-both-ends-k-wire-ref-128062-metallic-bone-fixation-fastener/) Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on... Class II Reported ongoing Distribution: US, Canada, Norway [Official source for DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3172-2024%22) Apr 24, 2024 FDA device enforcement ### [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](https://isitonrecall.com/recall/fda-device-z-1901-2024-smith-nephew-oxinium-femoral-head-12-14-taper-ref-71343204-32-mm-od-4-sterile-and-smith-nephew-12-14/) Packaging contained the incorrect size of femoral head from what was displayed on the label. Class II Reported ongoing Distribution: International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom. [Official source for smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&neph...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1901-2024%22) Sep 27, 2023 FDA device enforcement ### [JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis](https://isitonrecall.com/recall/fda-device-z-0157-2024-journey-ii-bcs-articular-insert-left-10-mm-size-5-6-ref-74027262-knee-prosthesis/) The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Japan. [Official source for JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0157-2024%22) Sep 27, 2023 FDA device enforcement ### [JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis](https://isitonrecall.com/recall/fda-device-z-0158-2024-journey-ii-bcs-constrained-articular-insert-size-5-6-10-mm-left-ref-74029262-knee-prosthesis/) The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Japan. [Official source for JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0158-2024%22) Aug 31, 2023 FDA device enforcement ### [smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint](https://isitonrecall.com/recall/fda-device-z-2621-2023-smith-nephew-legion-oxinum-posterior-stabilized-nonporous-fermoal-component-size-5n-left-narrow-ref/) The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label. Class II Reported ongoing Distribution: OH, CT, TX, NC, CA, NE, NV [Official source for smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARRO...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2621-2023%22) Jul 24, 2023 FDA device enforcement ### [TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail](https://isitonrecall.com/recall/fda-device-z-2443-2023-trigen-trochanteric-antegrade-nail-lime-11-5mm-x-36cm-130-degree-left-ref-71647336-femur-nail/) A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label. Class II Reported ongoing Distribution: US, AE, CA, DE, ES, GB, MX, PA, PL [Official source for TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2443-2023%22) Jul 24, 2023 FDA device enforcement ### [TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail](https://isitonrecall.com/recall/fda-device-z-2444-2023-trigen-trochanteric-antegrade-nail-lime-11-5mm-x-40cm-130-degree-left-ref-71647340-femur-nail/) A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label. Class II Reported ongoing Distribution: US, AE, CA, DE, ES, GB, MX, PA, PL [Official source for TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2444-2023%22) May 2, 2023 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-1670-2023-smith-nephew-engage-cementless-partial-knee-system-porous-femoral-components-part-numbers-a-ref-1-10/) Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art wi... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) R...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1670-2023%22) ## Reasons in these listed records - Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgi... - Removal of affected lot of screws due to labeling error. - Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes. - Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. These examples come from this result page and are not a ranking of every recall reason. ## Checking Smith & Nephew, Inc. ### Is there a recall on smith & nephew, inc. right now? This archive contains 33 records, including 27 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Smith & Nephew, Inc.](https://isitonrecall.com/check/?q=Smith%20%26%20Nephew%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)