Foundation Knee System, non-porous Femur Size 8, Right Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Foundation Knee System, non-porous Femur Size 8, Right
Lot Codes / Batch Numbers
Lot numbers 811761, 815241, 815251, 817891, 834781, 835291, 838201, 850611
Products Sold
Lot numbers 811761, 815241, 815251, 817891, 834781, 835291, 838201, 850611
A medical device manufacturer is recalling Foundation Knee System, non-porous Femur Size 8, Right due to Product container was labeled incorrectly indicating left femur instead of right.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product container was labeled incorrectly indicating left femur instead of right.
Recommended Action
Per FDA guidance
The firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, FL, MA, NV, PA, TX
Page updated: Jan 10, 2026