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
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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
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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 |
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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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