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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1951-2021
Event ID88010
Event DescriptionLEGION 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 TypeDevices
DistributionUS Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
Quantity5 units
Recall ReasonThe device components experienced a manufacturing process error that resulted in surface damage from product handling.
Device Classification20210630
Device Code InfoLot 20HM17607
Center Classification Date20210624
Recall Initiation Date20210519
Recalling FirmSmith & Nephew, Inc.
Initial Notification Letter
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