Product Wiki · Recalls · Health Canada — Medical Devices

PINNACLE ACETABULAR CUP SYSTEM (2021-05-13) — recall 62444

Health Canada — Medical Devices · Canada · 2021-05-26 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62444
Date of alert
2021-05-26
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: There is a potential of an out of specification condition (oversized "minor diameter") on certain PINNACLE® CUP devices. This correction is intended to advise physicians, who use the Apex HE, of the oversize condition of the hole in the cup, which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-threading". This may occur if the Apex HE is manipulated or toggled while threading it through the hole of certain PINNACLE® CUP.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/pinnacle-acetabular-cup-system

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