FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1135-2007
- Recalling firm
- Encore Medical, Lp
- Product
- 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.
- Status
- Terminated
- Initiated
- 2006-08-15
- Posted
- 2007-08-07
- Terminated
- 2008-03-27
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LKH
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28