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.
Reported: June 30, 2021 Initiated: May 19, 2021 #Z-1951-2021
Product Description
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.
Reason for Recall
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 5 units
- Distribution
- US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smith & Nephew, Inc.. Units affected: 5 units.
Why was this product recalled? ▼
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 30, 2021. Severity: Moderate. Recall number: Z-1951-2021.
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