Triathlon Femoral Distal Augments (10 AND 15 mm, SIZE 2, LEFT and RIGHT) (2019-08-09)
- Starting date:
- August 9, 2019
- Posting date:
- August 23, 2019
- 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-70793
Last updated: 2019-08-23
Affected Products
Triathlon Femoral Distal Augments (10 AND 15 mm, SIZE 2, LEFT and RIGHT)
Reason
Stryker has discovered [via customer product complaint PI# 1928452 - October 24 2018] that the Triathlon Femoral Distal Augments (10 and 15 mm, Size 2, Left and Right) protrude beyond the medial periphery of the mating femoral component.
Affected products
Triathlon Femoral Distal Augments (10 AND 15 mm, SIZE 2, LEFT and RIGHT)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5541-A-201
5541-A-202
5542-A-201
5542-A-202
Companies
- Manufacturer
-
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah
07430
UNITED STATES