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U.S. Department of Health and Human Services

Class 2 Device Recall Bencox Mirabo PE Liner36/44 Model Number: H1.L61.3644, UDI: 8806373852343

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  Class 2 Device Recall Bencox Mirabo PE Liner36/44 Model Number: H1.L61.3644, UDI: 8806373852343 see related information
Date Initiated by Firm February 27, 2017
Date Posted March 13, 2017
Recall Status1 Terminated 3 on May 11, 2017
Recall Number Z-1454-2017
Recall Event ID 76587
510(K)Number K162127  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
Code Information Lot Number: 10AFFQ21 Expiration Date: 2021-11-28
Recalling Firm/
Manufacturer		 CORENTEC CO., LTD
Seobuk-gu
12 Yeongsanhong 1-gil
Seobuk-gu, Cheonan-si Korea (the Republic of)
For Additional Information Contact US Agent - Rene van de Zande
512-327-9997
Manufacturer Reason
for Recall		 Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
FDA Determined
Cause 2		 Other
Action Corentec sent an Medical Device Recall letter dated February 23, 2017. The recalling firm notified the consignee via written notification by email and by phone. The recalled products will be returned to the recalling firm. For further questions please call (512) 327-9997
Quantity in Commerce 5 ea
Distribution US Distribution to the state of : PA
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 = LPH and Original Applicant = CORENTEC CO., LTD
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