Health product recall

Equinoxe Platform Fracture Stem 6.5mm & 10.5mm, Right (2019-12-03)

Starting date:
December 3, 2019
Posting date:
December 20, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71933

Last updated: 2019-12-20

Affected Products

Equinoxe Platform Fracture Stem 6.5mm & 10.5mm, Right

Reason

The implants are standard length fracture stems, but the translations on the outer label include the word "long" in all languages other than the original english version.

Affected products

Equinoxe Platform Fracture Stem 6.5mm & 10.5mm, Right

Lot or serial number

All lots.

Model or catalog number

304-22-07
304-22-11

Companies
Manufacturer
EXACTECH INC.
2320 NW 66TH COURT
GAINESVILLE
32653
Florida
UNITED STATES