CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report
Legion Oxinium Posterior Stabilized Nonporous Femoral recalled
Smith & Nephew is recalling Legion Oxinium Posterior Stabilized Nonporous Femoral Component, Size 5n, Right, Narrow, distributed in 7 states. The recall was initiated on 2 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0282-2025
- FDA event ID
- 95494
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Oct 2024
- FDA classified
- 31 Oct 2024
- Reported
- 6 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 2 Oct 2024 | Recall initiated by company | |
| 31 Oct 2024 | Classified by FDA | +29 days |
| 6 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
Where it was distributed
US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
AlabamaCaliforniaDelawareGeorgiaMississippiNorth CarolinaTennessee
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 00885556234204, Batch number 23LM02905
Where was it sold?
US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95494| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Genesis Ii Nonporous Posterior Stabilized Femoral Component recalled | Smith & Nephew | Packaging Defects | 7 states |
More recalls from Smith & Nephew
All 258| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trigen Proximal Straight Humeral Nail recalled by Smith & Nephew | Smith & Nephew | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Biosure HA Screw Threaded metallic bone fixation fastener recalled | Smith & Nephew | Labeling Errors | Nationwide |
| Device | CLASS II | Meta-tan Lag/compression Screw Kit recalled by Smith & Nephew | Smith & Nephew | Other | Nationwide |
| Device | CLASS II | Bioraptor Suture Anchors recalled by Smith & Nephew | Smith & Nephew | Sterility | Nationwide |
| Device | CLASS II | Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner recalled by Smith & Nephew | Smith & Nephew | Sterility | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |