Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.
Lot Codes / Batch Numbers
Lot #426142 and #426132.
Products Sold
Lot #426142 and #426132.
A medical device manufacturer is recalling Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement. due to The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
Recommended Action
Per FDA guidance
Firm initiated recall on 11/03/05 via letter to all consignees.
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, CA, FL, GA, IN, MO, NJ, OK, SC, SD, TX
Page updated: Jan 10, 2026