Health product recall

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

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

PINNACLE ACETABULAR CUP SYSTEM

Lot or serial number
  • 9675033
Model or catalog number
  • 1217-32-050
Companies
Manufacturer

Depuy Orthopaedics Inc.

700 Orthopaedics Drive

Warsaw

46582

Indiana

UNITED STATES