SwishPlus Implant (2018-01-04)

Starting date:

January 4, 2018

Posting date:

January 12, 2018

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-65648

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  Reason
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  Affected products

Affected products

SwishPlus Implant

Reason

The extender that is packaged with the Swish Tapered and SwishPlus Implant may have been packaged in the incorrect position (upside down in the plastic retainer).  This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible inflammation of the soft tissue to the patient.  This, in turn, may result in minor medical intervention by the Clinician.

Affected products