Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644… recallZ-1454-2017 · Corentec CO., Ltd · initiated Feb 27, 2017
Class II Terminated All recalls posted in March 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Corentec CO., Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
FDA root cause category: Other
What the company is doing
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
Recall details
- Recall number
- Z-1454-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 27, 2017
- Posted by the FDA
- Mar 13, 2017
- Recalling firm
- Corentec CO., Ltd
- Quantity
- 5 ea
- Product code
- LPH
- FDA submissions
- K162127
- Distribution
- US Distribution to the state of : PA
Product description
Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
Code information (models, lots, serial numbers)
Lot Number: 10AFFQ21 Expiration Date: 2021-11-28
Other devices under the same FDA submission
1 device cleared under K162127 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BENCOX Hip System HA.02I.0361Corentec Co., Ltd · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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