Smith & Nephew, Inc. Recall 88010
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.
Smith & Nephew, Inc. Recall 88010 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1951-2021 |
Event ID | 88010 |
Event 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. |
Product Type | Devices |
Distribution | US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution. |
Quantity | 5 units |
Recall Reason | The device components experienced a manufacturing process error that resulted in surface damage from product handling. |
Device Classification | 20210630 |
Device Code Info | Lot 20HM17607 |
Center Classification Date | 20210624 |
Recall Initiation Date | 20210519 |
Recalling Firm | Smith & Nephew, Inc. |
Initial Notification | Letter |
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