Health product recall

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