Recall Z-1139-2007
Encore Medical, Lp · initiated August 15, 2006
Product
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.
Codes / lots: M.I.K.A. Surgical Kits: MIKA-05-001, MIKA-05-002, MIKA-05-003, MIKA-05-004, MIKA-05-005, MIKA-05-006, MIKA-05-007, MIKA-05-008, MIKA-05-009, MIKA-05-010, MIKA-05-016, MIKA-05-018, MIKA-05-019, MIKA-05-020, MIKA-05-021, MIKA-05-022, MIKA-05-023, MIKA-05-024, MIKA-05-025, MIKA-05-026, MIKA-05-027, MIKA-05-028, MIKA-05-029, and MIKA-05-030.
Reason for recall
Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-1139-2007
- Initiated
- August 15, 2006
- Posted by FDA
- August 7, 2007
- Terminated
- March 27, 2008
- Product code
- LKH – Antisera, Immunoperoxidase, Chlamydia Spp.
- Quantity
- 24 units.
- Distribution
- Product distributed to direct accounts in USA and one consignee in Japan.
- Recalling firm
- Encore Medical, Lp, Austin, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1135-2007 | Femoral Speed Block Size 2, Part/Catalog #800-01-365; positioning device included as…Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | 08/15/2006Terminated |
| Z-1136-2007 | Femoral Speed Block Size 4 Part/Catalog #800-01-366; positioning device included as part…Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | 08/15/2006Terminated |
| Z-1137-2007 | Femoral Speed Block Size 6, Part/Catalog #800-01-367; positioning device included as…Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | 08/15/2006Terminated |
| Z-1138-2007 | Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as…Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | 08/15/2006Terminated |
| Z-1140-2007 | Femoral Speed Block Size 12, Part/Catalog #800-01-370; positioning device included as…Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | 08/15/2006Terminated |