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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-0086-2008
Recall Event ID 44788
510(K)Number K953510  
Product Classification hip prosthesis - Product Code KWY
Product Foundation¿ Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #: 640791, 640801, 640811, 677101, 677111, 678581, 678591, 678601, 678611, 678621, 679611, 679621, 693841, 693851, 693861, 695121, 695861, 697851, 697861, 698771, 730141, 730221, 731481, 003612, 003622, 003632, 003642, 208672, 735781, 736431, 736441, 736451, 736461, 736751, 737391, 738431, 738891, 738911, 770081, 770191, 772371, 776721, 778421, 780161, 783931, 788381, 788391, 794401, 795481, 795491, 812181, 812191, 812201, 812211, 813511, 817551, 817561, 833181, 833191, 834981, 834991, 837691, 837791, 842321, 842331, 847351, 847361, 847391, 847401, 854341, 854381, 854391, 854401, 854411, 857691, 857701, 874991, 875001, 878331, 878351, 878531, 878541, 882611, 882621, 882631, 891271, 891281, 891301, 893631, 893641, 905571, 905581, 907081, 907091, 907101, 907111, 925761, 925771, 932731, 932741, 938211, 938221, 949431, 949441, 951081, 964251, 964261, 964271, 964281, 964291, 964301, 964311 and 421494A.
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 776 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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