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U.S. Department of Health and Human Services

Class 2 Device Recall Margron DTC Hip Replacement System.

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  Class 2 Device Recall Margron DTC Hip Replacement System. see related information
Date Initiated by Firm January 11, 2008
Date Posted September 18, 2008
Recall Status1 Terminated 3 on November 12, 2009
Recall Number Z-1994-2008
Recall Event ID 47369
510(K)Number K992815  K032641  
Product Classification Hip joint - Product Code MEH
Product Margron DTC Hip Replacement System; Margron hip extension module AA7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-202. Product is used for Orthopedic surgery.
Code Information All lots.
Recalling Firm/
Manufacturer		 Portland Orthopaedics Pty, Ltd.
1 South Street, Suite 3, Level 5
Saint George Hospital
Kogarah Australia
For Additional Information Contact
810-3293348
Manufacturer Reason
for Recall		 Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
FDA Determined
Cause 2		 Device Design
Action Stocks were pulled from U.S. consignees on or before 1/11/08. Consignee and implanting surgeon letters dated 6/20/08 were sent advising of the issue and recommending patient monitoring. For assistance, contact Portland Orthopaedics at 1-810-329-3348.
Quantity in Commerce 2403 of all products
Distribution Nationwide.
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 = MEH and Original Applicant = PORTLAND ORTHOPAEDICS PTY. LTD.
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