| Class 2 Device Recall MIKA Speedblock | |
Date Initiated by Firm | April 26, 2010 |
Date Posted | August 02, 2010 |
Recall Status1 |
Terminated 3 on December 15, 2011 |
Recall Number | Z-2164-2010 |
Recall Event ID |
55605 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
|
For Additional Information Contact | 512-832-9500 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 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. |
Quantity in Commerce | 729 and 67 specials |
Distribution | Worldwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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