Smith & Nephew, Inc.

Complete recall history across all FDA and CPSC categories — 220 total recalls

Smith & Nephew, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (220)

FDA medical device enforcement actions by Smith & Nephew, Inc.. Showing most recent 50.

Date Product Reason Class
Nov 24, 2025 BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. Removal of affected lot of screws due to labeling error. Class II
Mar 18, 2025 META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 Integrated Lag/Compression Screw Kit has a compression screw with hexagon soc... Class II
Oct 15, 2024 Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I... The Bipolar assembly contains an oversized Retainer Ring. Class II
Jul 9, 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 ... Class II
Jul 9, 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 ... Class II
Sep 27, 2023 JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee pros... The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and pa... Class II
Sep 27, 2023 JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 7402926... The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and pa... Class II
Jul 24, 2023 TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71... A complaint was received indicating that a package contained a TRIGEN TROCHAN... Class II
Jul 24, 2023 TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71... A complaint was received indicating that a package contained a TRIGEN TROCHAN... Class II
May 2, 2023 Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Par... Recent complaint data indicates that the revision rate may be trending higher... Class II
May 2, 2023 Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part ... Recent complaint data indicates that the revision rate may be trending higher... Class II
May 2, 2023 Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components... Recent complaint data indicates that the revision rate may be trending higher... Class II
May 2, 2023 Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part ... Recent complaint data indicates that the revision rate may be trending higher... Class II
Mar 27, 2023 JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM A mispack occurred during the manufacturing process, resulting in the box inc... Class II
Jun 27, 2022 (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. ... The product was mispackaged (swapped). The devices within the inner tray mat... Class II
Jan 4, 2022 INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND The affected screwdrivers are out of specification and may not mate with the ... Class II
Dec 14, 2021 Acufex Access Advanced Positioning Kit - indicated for use to position and di... Products were shipped to the Global Distribution Center instead of the steril... Class II
Nov 1, 2021 smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201 Testing vendor notified Smith & Nephew that previous MRI scanning conditions ... Class II
Nov 1, 2021 smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202 Testing vendor notified Smith & Nephew that previous MRI scanning conditions ... Class II
Nov 1, 2021 smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102 Testing vendor notified Smith & Nephew that previous MRI scanning conditions ... Class II
Nov 1, 2021 smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 Testing vendor notified Smith & Nephew that previous MRI scanning conditions ... Class II
Oct 25, 2021 Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM... The labels on the packages of screws were switched. Class II
Sep 20, 2021 6.5MMX165MM CANNULATED SCREW The product label incorrectly indicated that the screws are fully threaded, b... Class II
May 19, 2021 LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, ... The device components experienced a manufacturing process error that resulted... Class II
Apr 8, 2021 CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for int... Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw Class II
Dec 18, 2020 VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product ... Potential heat and humidity exposure. The affected lot contained an atypical ... Class II
Nov 2, 2020 Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures ... Manufacturing packaging error. Class II
Sep 21, 2020 Genesis (GII) - Product Usage: designed for use in patients in primary and re... The anterior locking detail does not meet its design specifications. Class II
Sep 21, 2020 5.5MM Arthrogarde Hip Access Cannula The J Lock feature on the cannula body was manufactured incorrectly, preventi... Class II
Sep 9, 2020 TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Numbe... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Nu... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 7... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Num... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Num... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991 Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Nu... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702 Product packaging improper or incomplete seal of the pouch surrounding the st... Class II
Sep 9, 2020 TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the st... Class II

View all 220 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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