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Triathlon Total Knee System - Ts Femoral Component
- Starting date:
- June 29, 2017
- Posting date:
- July 18, 2017
- 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-64006
Reason
It was discovered during manufacturing, that size 3 and 4 Triathlon Cemented Revision Femoral components had excess metal trapped in the size and lot code marking imprints. Analysis showed that the material trapped in the imprint was 304 stainless steel blast media, which is used to grit blast the implants during the manufacturing process.
Affected products
Triathlon Total Knee System - Ts Femoral Component
Lot or serial number
AGD9R
Model or catalog number
5512-F-301
Companies
- Manufacturer
-
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah
07430
UNITED STATES