Z-1454-2017Class II

Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343

Name: Z-1454-2017 Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
Creator: Corentec Co., Ltd
Published: 2017-02-27
License: https://open.fda.gov/license/

Corentec Co., Ltd. / initiated 2017-02-27 / Terminated / root cause: labeling and UDI

FDA source

CORENTEC CO., LTD began a recall of Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343 on 2017-02-27. FDA classified it as Class II and gives the reason as "Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1454-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-27
Posted: 2017-03-13
Terminated: 2017-05-11
Recalling firm: Corentec Co., Ltd.
Product: Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Lot Number: 10AFFQ21 Expiration Date: 2021-11-28

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1454-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1454-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13

Product code LPH

K162127Class IIBencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. / cleared 2016-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)