Recall Z-0826-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left
| Date | Feb 24, 2010 (initiated Dec 11, 2009) |
| Status | Terminated |
| Reason | Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method. |
| Root cause | Process control |
| Action | Firm notified consignees by letter on 12/11/2009. The letter informs physicians that patients with implanted devices should counseled about the issue and should report any changes to their treating physician. |
| Quantity | 17 |
| Distribution | TX, FL, GA, CA, AZ, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932425 | FOUNDATION MODULAR TIBIAL BASEPLATE Encore Orthopedics, Inc., Jul 22, 1994 |