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

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

SwishPlus Implant

Lot or serial number

64927

Model or catalog number

924112

Companies
Manufacturer
Implant Direct Sybron Manufacturing LLC
3050 East Hillcrest Drive
Thousand Oaks
91362
California
UNITED STATES