Health product recall

SPECIALTY TRIATHLON TS TRIAL CUTTING GUIDE (2021-03-04)

Starting date:
March 4, 2021
Posting date:
March 16, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-75135

Last updated: 2021-03-16

Affected Products

SPECIALTY TRIATHLON TS TRIAL CUTTING GUIDE

Reason

Stryker has discovered that the posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Specialty Triathlon TS Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery. Stryker is aware of complaints associated with the issue. There have been no reports of serious injuries due to the failure mode associated with this recall.

Affected products

SPECIALTY TRIATHLON TS TRIAL CUTTING GUIDE

Lot or serial number

AP15C09

Model or catalog number

I-K3834CG00

Companies
Manufacturer
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah
07430
New Jersey
UNITED STATES