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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-0090-2008
Recall Event ID 44788
510(K)Number K953510  
Product Classification hip prosthesis - Product Code KWY
Product Foundation¿ Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #: 546541, 675911, 677601, 678771, 678781, 693911, 693921, 695081, 697091, 697811, 699931, 730251, 732541, 732851, 735731, 736531, 736781, 739441, 770131, 777441, 777451, 781061, 783961, 788501, 788511, 794411, 794421, 797051, 830291, 830301, 830951, 835571, 835581, 842391, 842401, 844611, 854991, 857781, 872031, 872041, 872051, 872061, 878571, 878581, 885411, 885421, 892351, 892361, 892371, 892381, 905621, 905881, 907221, 933841, 933851, 933861, 938261, 939751, 944281, 944291, 964381, 964391, 964401, 982741 and 421521A.
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 377 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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