PINNACLE ACETABULAR CUP SYSTEM (2021-05-13)

Starting date:

May 13, 2021

Posting date:

May 26, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-75665

Last updated:
2021-05-26

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  Reason
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  Affected products

Affected Products

PINNACLE ACETABULAR CUP SYSTEM

Reason

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.

Affected products