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