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U.S. Department of Health and Human Services

Class 2 Device Recall Foundation Hip System Bipolar Modular

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  Class 2 Device Recall Foundation Hip System Bipolar Modular see related information
Date Initiated by Firm August 02, 2007
Date Posted November 07, 2007
Recall Status1 Terminated 3 on January 09, 2008
Recall Number Z-0084-2008
Recall Event ID 44788
510(K)Number K953510  
Product Classification hip prosthesis - Product Code KWY
Product Foundation¿ Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #: 644021, 648331, 672341, 675901, 678461, 678471, 678481, 678491, 678501, 678511, 678521, 693251, 694501, 697771, 732831, 733871, 736411, 736741, 738071, 738081, 738411, 738421, 770041, 774781, 774791, 777391, 779571, 779581, 783901, 783911, 788351, 794371, 794381, 811151, 811161, 835501, 835511, 836161, 844591, 845951, 848661, 854461, 854471, 854481, 854491, 857681, 874941, 874951, 882561, 882571, 882581, 893551, 893561, 893571, 903121, 903131, 933751, 944241, 944251, 949391, 949401, 964171, 964181, 964191 and 964201.
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-834-6235
Manufacturer Reason
for Recall		 Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
FDA Determined
Cause 2		 Packaging change control
Action Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
Quantity in Commerce 382 units.
Distribution Worldwide, including USA, Greece, Japan, and Saudi Arabia.
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 = KWY and Original Applicant = ENCORE ORTHOPEDICS, INC.
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