3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
This recall has been terminated (originally issued July 20, 2004).
- Recall Initiated
- May 10, 2004
- Posted
- July 20, 2004
- Terminated
- August 9, 2004
- Recall Number
- Z-1011-04
- Quantity
- 16
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE
Distribution
Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany.
Lot / Code Info
Catalog number 333-02-106; Lot numbers 991141 and 991131
Root Cause
Other
Action Taken
The firm sent recall letters to all consignees on May 10, 2004 requesting return of the product.