Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.
This recall has been terminated (originally issued December 29, 2005).
- Recall Initiated
- November 3, 2005
- Posted
- December 29, 2005
- Terminated
- April 4, 2008
- Recall Number
- Z-0332-06
- Quantity
- 14 units.
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.
Lot / Code Info
Lot #434322.
Root Cause
Other
Action Taken
Firm initiated recall on 11/03/05 via letter to all consignees.