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U.S. Department of Health and Human Services

Class 2 Device Recall Osteopore

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  Class 2 Device Recall Osteopore see related information
Date Initiated by Firm April 27, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on June 06, 2012
Recall Number Z-0446-2012
Recall Event ID 59231
510(K)Number K051093  
Product Classification bone filler - Product Code GXP
Product Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh.
Code Information Serial number LP-07-000695-714, lot number P0009032007-NW-05, expiry date Jul-12; Serial number TT-07-002201-2500, lot number P0009032007-NW-05, expiry date Sep-12; and Serial number PL-09-000006 to 15, lot number P0010112007-NW-05, expiry date Dec-12.
Recalling Firm/
Manufacturer		 OSTEOPORE INTERNATIONAL PTE LTD
10, SCIENCE PARK ROAD
THE ALPHA, #02-28
SINGAPORE Singapore
Manufacturer Reason
for Recall		 Product sterility may be compromised.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Osteopore sent an Urgent Voluntary Product Recall notice to their consignees by letter dated April 27, 2011.
Quantity in Commerce 330
Distribution Nationwide distribution - one distributor in TX.
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 = GXP and Original Applicant = OSTEOPORE, INC.
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