Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as part of the M.I.K.A. (Minimally Inv
FDA device recall Z-1138-2007 · posted 2007-08-07 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
- Action taken
- 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
- Status
- Terminated
- Product code
- LKH
- Quantity affected
- 24 units.
- Distribution
- Product distributed to direct accounts in USA and one consignee in Japan.
- Date initiated
- 2006-08-15
- Date posted
- 2007-08-07
- Date terminated
- 2008-03-27
- Location
- Austin, TX
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