CLASS II ONGOING Device recall · Reported 27 Sep 2023 · FDA Enforcement Report
Legion Oxinum Posterior Stabilized Nonporous Fermoal recalled
Smith & Nephew is recalling smith&nephew Legion Oxinum Posterior Stabilized Nonporous Fermoal Component, Size 5N, distributed in 7 states. The recall was initiated on 31 Aug 2023 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-2621-2023
- FDA event ID
- 92976
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Aug 2023
- FDA classified
- 20 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 31 Aug 2023 | Recall initiated by company | |
| 20 Sep 2023 | Classified by FDA | +20 days |
| 27 Sep 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
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 OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Where it was distributed
OH, CT, TX, NC, CA, NE, NV
Questions about this recall
Is Legion Oxinum Posterior Stabilized Nonporous Fermoal Component, Size 5n, Left, Narrow recalled?
Yes. Smith & Nephew recalled Legion Oxinum Posterior Stabilized Nonporous Fermoal Component, Size 5n, Left, Narrow on 31 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-2621-2023.
Why was it recalled?
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.
Which lots are affected?
UDI/DI: 00885556234006, Lot Number: 23EM09878
Where was it sold?
OH, CT, TX, NC, CA, NE, NV
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.
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