3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.
Lot Codes / Batch Numbers
Lot #53906407
Products Sold
Lot #53906407
A medical device manufacturer is recalling 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L. due to Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly mark. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.
Recommended Action
Per FDA guidance
Firm notified consignee by phone and asked them to return any outstanding product on 02/20/08.
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 noticePage updated: Jan 10, 2026