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Terminated

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

FDA Recall Z-1454-2017 · Posted 2017-03-13

Recalling FirmCORENTEC CO., LTD
Recall StatusTerminated
Product CodeLPH
Date Initiated2017-02-27
Date Terminated2017-05-11
Product Quantity5 ea

Reason for Recall

Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.

Firm 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

Root Cause

Other

Distribution Pattern

US Distribution to the state of : PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016-12-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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