Recall Z-0010-2008 ยท HWA Impactor
Encore Medical, Lp
EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
| Date | Oct 10, 2007 (initiated Aug 9, 2007) |
| Status | Terminated |
| Reason | Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site. |
| Root cause | Device Design |
| Action | Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements. |
| Quantity | 5 units. |
| Distribution | Products distributed to direct accounts in CA, FL and MD. |
| FDA record | Open on fda.gov |