Femoral Speed Block Size 10, Part/Catalog #800-01-369; 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.
FDA Recall Z-1139-2007 · Posted 2007-08-07
Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeLKH
Date Initiated2006-08-15
Date Terminated2008-03-27
Product Quantity24 units.
Reason for Recall
Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
Firm 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.
Root Cause
Other
Distribution Pattern
Product distributed to direct accounts in USA and one consignee in Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.