SIGMA HP PFJ Cemented Trochlear Implants (2017-12-22)

Starting date:
December 22, 2017
Posting date:
January 12, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-65674

Affected products

SIGMA HP PFJ Cemented Trochlear Implants

Reason

DePuy Orthopaedics Inc. is recalling the SIGMA HP PFJ Cemented Trochlear Implants. This decision is based on elevated revision rates observed as part of the company's post market surveillance process.

Affected products

SIGMA HP PFJ Cemented Trochlear Implants

Lot or serial number

All lots.

Model or catalog number

1024-03-100
1024-03-200
1024-03-300
1024-03-400
1024-03-500
1024-04-100
1024-04-200
1024-04-300
1024-04-400
1024-04-500

Companies
Manufacturer
DePuy Orthopaedics Inc.
700 Orthopaedics Drive, P.O. Box 988
Warsaw
46581
Indiana
UNITED STATES