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U.S. Department of Health and Human Services

Class 2 Device Recall Encore Reverse Shoulder Prosthesis

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  Class 2 Device Recall Encore Reverse Shoulder Prosthesis see related information
Date Initiated by Firm July 28, 2005
Date Posted September 21, 2005
Recall Status1 Terminated 3 on April 19, 2007
Recall Number Z-1566-05
Recall Event ID 32909
510(K)Number K041066  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
Code Information Catalog number: 506-00-006, lot numbers: 260212, 260222, and 244642;  Catalog number: 506-00-007, lot number: 250272;  Catalog number: 506-00-008, lot numbers: 260242, 254342, 260252, 244662, and 244312;  Catalog number: 507-06-175, lot numbers: 261832, 244732, 967721, and 006192;  Catalog number: 507-08-175, lot numbers: 261842, 241392, 872681, and 872671
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
Manufacturer Reason
for Recall		 Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.
FDA Determined
Cause 2		 Other
Action Recall was initiated by letter to sales agents on 07/28/2005.
Quantity in Commerce 93 primary units and 56 revision units
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 = JWH and Original Applicant = ENCORE MEDICAL, L.P.
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