Modular Reverse Reamer (2017-05-23)

Starting date:

May 23, 2017

Posting date:

August 14, 2017

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-64152

• Reason
• Affected products

Affected Products

1. Modular Reverse Reamer Starter, Pilot Tip
2. Modular Reverse Reamer Pilot Tip

Reason

This advisory notice has been issued because Exactech has updated the surgical technique for implantation of the Equinoxe Platform Shoulder System to clarify the proper technique for use of the pilot tip reamers i.e., to include a caution statement that the surgeon should avoid applying a bending force to the pilot tip reamer and should avoid using the reamer to retract the humeral head, as this may result in instrument breakage.

Affected products