Recall Z-1135-2007 ยท LKH Antisera, Immunoperoxidase, Chlamydia Spp.
Encore Medical, Lp
Femoral Speed Block Size 2, Part/Catalog #800-01-365; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Austin, TX 78758.
| Date | Aug 7, 2007 (initiated Aug 15, 2006) |
| Status | Terminated |
| Reason | Complaints received that device used to prepare femur to receive femoral implant would split during surgery. |
| Root cause | Other |
| Action | Firm sent notification letter to consignees on 08/25/2006, along with replacement speedblocks. Consignees asked to trade out old speedblocks with the replacements. |
| Quantity | 24 units. |
| Distribution | Product distributed to direct accounts in USA and one consignee in Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.