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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