Z-1138-2007

Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as part of the M.I.K.A...

Name: Z-1138-2007 Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as part of the M.I.K.A...
Creator: Encore Medical, Lp
Published: 2006-08-15
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2006-08-15 / Terminated

FDA source

Encore Medical, Lp began a recall of Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit... on 2006-08-15. The reason FDA records is "Complaints received that device used to prepare femur to receive femoral implant would split during surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1138-2007
Status: Terminated
Initiated: 2006-08-15
Posted: 2007-08-07
Terminated: 2008-03-27
Recalling firm: Encore Medical, LP
Product: Femoral Speed Block Size 8, Part/Catalog #800-01-368; 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.
Product code: LKH Antisera, Immunoperoxidase, Chlamydia Spp.
Reason for recall: Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
FDA 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 in commerce: 24 units.
Distribution: Product distributed to direct accounts in USA and one consignee in Japan.
Product codes and 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.

Product code LKH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)