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U.S. Department of Health and Human Services

Class 2 Device Recall ALFA II Modular Femoral Left Modular Stem

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  Class 2 Device Recall ALFA II Modular Femoral Left Modular Stem see related information
Date Initiated by Firm April 12, 2007
Date Posted July 23, 2007
Recall Status1 Terminated 3 on July 25, 2007
Recall Number Z-1065-2007
Recall Event ID 37881
510(K)Number K000817  
Product Classification Hip replacement prosthesis component - Product Code JDI
Product ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot #Y131E and 2475.
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
Manufacturer Reason
for Recall
Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
FDA Determined
Cause 2
Action Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P.
Quantity in Commerce 2 units.
Distribution Product distributed to surgical centers in CT, KS and MO.
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 = JDI and Original Applicant = OSTEOIMPLANT TECHNOLOGY, INC.