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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-0083-2008
Recall Event ID 44788
510(K)Number K953510  
Product Classification hip prosthesis - Product Code KWY
Product Foundation¿ Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #: 602661, 691241, 633821, 633861, 738401, 770031, 777381, 792451, 797031, 811141, 831041, 836151, 845221, 848651, 857671, 878321, 905551, 932691, 949381, 958921 and 964161.
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 111 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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