Date Initiated by Firm |
January 11, 2008 |
Date Posted |
September 18, 2008 |
Recall Status1 |
Terminated 3 on November 12, 2009 |
Recall Number |
Z-1957-2008 |
Recall Event ID |
47369 |
510(K)Number |
K992815 K032641
|
Product Classification |
Hip joint - Product Code MEH
|
Product |
Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-021. 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
|
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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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