Recall Z-1454-2017 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
CORENTEC CO., LTD
Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
| Date | Mar 13, 2017 (initiated Feb 27, 2017) |
| Status | Terminated |
| Reason | Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use. |
| 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 | 5 ea |
| Distribution | US Distribution to the state of : PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System Corentec Co., Ltd., Dec 5, 2016 |