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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-0087-2008
Recall Event ID 44788
510(K)Number K953510  
Product Classification hip prosthesis - Product Code KWY
Product Foundation¿ Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #: 629071, 677121, 677131, 678651, 678661, 678671, 678681, 679641, 691251, 691261, 691271, 693871, 693881, 694511, 694521, 694531, 695111, 697791, 698971, 698981, 730201, 731491, 733951, 734531, 736471, 736481, 736761, 738091, 738101, 738901, 770091, 772351, 772361, 777411, 780171, 783941, 788411, 788421, 795501, 795511, 812221, 813521, 813531, 814301, 814311, 817571, 834021, 834031, 835551, 836171, 842341, 842351, 845961, 847381, 854351, 854421, 854431, 854441, 855871, 855881, 857721, 875011, 875021, 878341, 878361, 878551, 878561, 891291, 891311, 893621, 894391, 894401, 905591, 905601, 907061, 907071, 925781, 925791, 932751, 938231, 938241, 938251, 949451, 949461, 951091, 959761, 959771, 964321, 964331, 964341 and 964351.
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 632 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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