Star Total Ankle Replacement - Sliding Core (2019-10-24)

Starting date:

October 24, 2019

Posting date:

November 8, 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-71559

Last updated: 2019-11-08

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  Reason
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  Affected products

Affected Products

Star Total Ankle Replacement - Sliding Core

Reason

Stryker has become aware of data indicating that patients implanted with the Star Total Ankle Replacement distributed prior to August 1, 2014 may experience a higher than expected risk of polyethylene fracture due to potential increase in polyethylene oxidation prior to or after implantation and potentially the implant geometry (as reported in published literature).

Affected products