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U.S. Department of Health and Human Services

Class 2 Device Recall Femoral Cut Block

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  Class 2 Device Recall Femoral Cut Block see related information
Date Initiated by Firm June 24, 2015
Date Posted July 27, 2015
Recall Status1 Terminated 3 on June 24, 2016
Recall Number Z-2262-2015
Recall Event ID 71663
Product Classification Template - Product Code HWT
Product FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Code Information Lot 53839799 and 414012
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Desiree Hubby
512-832-9500
Manufacturer Reason
for Recall		 The markings on the distal face of the instruments are mis-oriented by 180¿. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrument in the A/P direction is critical to making proper anterior, posterior, and chamfer cuts to fit the femoral implant.
FDA Determined
Cause 2		 Component design/selection
Action DJO Surgical sent an " Urgent Field Safety Notice" dated June 30, 2015, to the affected customer. The recalling firm requested the customer return the affected product for a replacement. For further questions, please call (512) 834-6302.
Quantity in Commerce 10 units
Distribution US Distribution to TX and GA.
Total Product Life Cycle TPLC Device Report
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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