Recall Z-0622-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary stem are attached to the metal baseplate intraoperatively.
| Date | Jan 13, 2010 (initiated Dec 3, 2009) |
| Status | Terminated |
| Reason | Product does not meet specifications for a size 8 Right Foundation Tibia Baseplate. |
| Root cause | Mixed-up of materials/components |
| Action | Firm notified consignees by an Urgent Field Safety Notice dated 12/3/2009. The letter identified the product, stated the problem, and the risk associated with the problem. Customers are to immediately return the affected product and notify all of their customers if product was further distributed. Customers are to complete and return the enclosed response form. Questions should be directed to David Harris, Manager of Customer Service at 512-834-6330 or Valerie Moulton, International Customer Service at 512-834-6275. |
| Quantity | 17 |
| Distribution | Worldwide Distribution -- USA, including states of GA, OK, FL, CA, and SD, and countries of Germany and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932425 | FOUNDATION MODULAR TIBIAL BASEPLATE Encore Orthopedics, Inc., Jul 22, 1994 |