CLASS II Device recall · Reported 30 Jun 2021 · FDA Enforcement Report
Legion Posterior Stabilized Oxinium Femoral Component recalled
Smith & Nephew is recalling Legion Posterior Stabilized Oxinium Femoral Component, distributed nationwide in the US. The recall was initiated on 19 May 2021 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-1951-2021
- FDA event ID
- 88010
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 May 2021
- FDA classified
- 24 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 19 May 2021 | Recall initiated by company | |
| 24 Jun 2021 | Classified by FDA | +36 days |
| 30 Jun 2021 | 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
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Product as listed by the FDA
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
Where it was distributed
US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
Questions about this recall
Why was it recalled?
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Which lots are affected?
Lot 20HM17607
Where was it sold?
US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
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 26 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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