3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
Lot Codes / Batch Numbers
Catalog number 333-02-106, Lot numbers 991141 and 991131
Products Sold
Catalog number 333-02-106; Lot numbers 991141 and 991131
A medical device manufacturer is recalling 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopead due to Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE
Recommended Action
Per FDA guidance
The firm sent recall letters to all consignees on May 10, 2004 requesting return of the product.
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
CA, FL, IN, IA, MA, OK, SD, TX
Page updated: Jan 10, 2026