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

FDA device recall Z-2164-2010 · posted 2010-08-02 · Terminated

Recall details

Recalling firm

Encore Medical, Lp

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.

Action taken

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 beth.onderlinde@djosurgical.com 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 info@mdss.com or via phone at +49 (0) 511 6262 8630.

Root cause

Component design/selection

Status

Terminated

Product code

LXH

Quantity affected

729 and 67 specials

Distribution

Worldwide distribution.

Date initiated

2010-04-26

Date posted

2010-08-02

Date terminated

2011-12-15

Location

Austin, TX