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
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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)
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LPH
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