Z-2164-2010

MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the...

Name: Z-2164-2010 MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the...
Creator: Encore Medical, Lp
Published: 2010-04-26
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2010-04-26 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts on 2010-04-26. The reason FDA records is "A crack or complete fracture at the anterior chamfer cut slot may occur on the size 8, 10, and 12 MIKA Speedblocks". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2164-2010
Status: Terminated
Initiated: 2010-04-26
Posted: 2010-08-02
Terminated: 2011-12-15
Recalling firm: Encore Medical, LP
Product: MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: A crack or complete fracture at the anterior chamfer cut slot may occur on the size 8, 10, and 12 MIKA Speedblocks.
Root cause tag: design
FDA root cause: Component design/selection
Action: An "Urgent Field Safety Notice" Letter dated May 20, 2010, was sent to the customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to locate, inspect and verify the quantity still in their possession, complete and return the field safety notice response page to Beth Onderlinde at [email protected] or fax to 512-834-6313 by June 7, 2010, (completion of form is mandatory), and identify and inform customers that they may have distributed/sold product to, of the notice. The customer was also instructed to please inspect the listed part numbers prior to use and again after use, if a crack is found in the speedblock, contact your Customer Service Representative and be sure to utilize the femoral/tibial impactor (801-01-043) for impaction of the speedblock and reiterate to your physicians that the MIKA mini slaphammer (800-02-290) should be used for speedblock removal. The product will be replaced as it becomes available. If you have any questions, call Director of Commercial Logistics at (512) 834-6330 or International Customer Service at (512) 834-6275. You may also contact our EU Authorized Representative, MDSS GmbH, via email at [email protected] or via phone at +49 (0) 511 6262 8630.
Quantity in commerce: 729 and 67 specials
Distribution: Worldwide distribution.
Product codes and lots: Model/Catalog Numbers: 800-01-368/370; 800-02-343/345; Specials that are affected: S1028, S1046, S1130, S1135, S1305, S1366, S1373, S1374, S1375, S1403, S1468, S1469, S1470, S1511, S1512, S1513

Product code LXH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)