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U.S. Department of Health and Human Services

Class 2 Device Recall Foundation NonPorous Hip System

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  Class 2 Device Recall Foundation NonPorous Hip System see related information
Date Initiated by Firm August 17, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on May 11, 2012
Recall Number Z-0418-2012
Recall Event ID 59739
510(K)Number K961890  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, - Product Code JDI
Product FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm

DJO Surgical 9800 Metric Blvd., Austin, TX 78758

The Foundation Non-Porous Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with bone cement.
Code Information All devices packaged prior to July 1, 2008. Model/Catalog Number: 460-01-090, 460-01-105, 460-01-120, 460-01-135, 460-01-150, 460-01-165
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact David Harris
512-834-6330
Manufacturer Reason
for Recall		 The sterility has the potential to be compromised.
FDA Determined
Cause 2		 Packaging
Action Encore Medical Lp sent a Urgent Field Safety Notice dated August 17, 2011. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately quarantine these devices if you have not already done so. Contact Customer Service to obtain replacement devices as well as an RMA. Return all affected devices by October 31, 2011, using the RMA Customer Service provided in step #3. If you have any further questions you may call (512 ) 834-6330. For International Customer Service please call (512) 834-6275.
Quantity in Commerce 169 units
Distribution Worldwide Distribution -- USA ( nationwide ) including the states of WI, NY, MO, TX, FL, CA, UT, AZ, Puerto Rico, and the country Japan.
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.
510(K) Database 510(K)s with Product Code = JDI and Original Applicant = ENCORE ORTHOPEDICS, INC.
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