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

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  Reason
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  Affected products

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