Smith & Nephew Inc

Complete recall history across all FDA and CPSC categories — 26 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 (26)

FDA medical device enforcement actions by Smith & Nephew Inc

Date Product Reason Class
Oct 2, 2024 smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 L... Complaint received indicating that a package contained a LGN OX CONSTRAINED F... Class II
Oct 2, 2024 smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZ... Complaint received indicating that a package contained a LEGION NARROW PS OXI... Class II
Oct 2, 2024 smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT,... Complaint received indicating that a package contained a LEGION NARROW PS OXI... Class II
Oct 2, 2024 smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 L... Complaint received indicating that a package contained a LGN OX CONSTRAINED F... Class II
Apr 24, 2024 smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Ste... Packaging contained the incorrect size of femoral head from what was displaye... Class II
Aug 31, 2023 smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, ... The firm conducting a recall due to a complaint received indicating that a pa... Class II
Apr 19, 2022 LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5 It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labell... Class II
Apr 4, 2014 TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT... A manufacturing error resulted in the set screw being inserted too deep in th... Class II
Apr 4, 2014 TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) RE... A manufacturing error resulted in the set screw being inserted too deep in th... Class II
Jan 23, 2014 Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, ... Inner spherical radius of the shell is undersized. Class II
Nov 25, 2013 REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-5... One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of ... Class II
Oct 7, 2013 GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. ... Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 ... Class II
Oct 7, 2013 GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188.... Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 ... Class II
Aug 27, 2013 GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), R... The Tyvek(TM) lid on one, or both, of the two trays that form a double barri... Class II
Aug 27, 2013 GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), ... The Tyvek(TM) lid on one, or both, of the two trays that form a double barri... Class II
Aug 27, 2013 GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), R... The Tyvek(TM) lid on one, or both, of the two trays that form a double barri... Class II
Aug 27, 2013 GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), R... The Tyvek(TM) lid on one, or both, of the two trays that form a double barri... Class II
Aug 27, 2013 GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), RE... The Tyvek(TM) lid on one, or both, of the two trays that form a double barri... Class II
Aug 27, 2013 GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1... The Tyvek(TM) lid on one, or both, of the two trays that form a double barri... Class II
Jul 8, 2013 GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM... The products were produced using the wrong color material, resulting in the d... Class II
May 29, 2013 R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: ... One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62... Class II
May 29, 2013 R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: ... One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62... Class II
Mar 6, 2013 TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF ... One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly ... Class II
Feb 7, 2013 INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAP... 75 mm screws were packaged and labeled using an 80 mm screw outer box and lab... Class II
Feb 7, 2013 INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAP... 75 mm screws were packaged and labeled using an 80 mm screw outer box and lab... Class II
Aug 22, 2012 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL ... Modular necks were manufactured out of specification by a vendor; the taper p... Class II

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.

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