Exactech, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2663-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01

Product Classification:

Class II

Date Initiated: May 25, 2017

Date Posted: July 12, 2017

Recall Number: Z-2663-2017

Event ID: 77004

Reason for Recall:

Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.

Status: Terminated

Product Quantity: 382

Code Information:

All Lots

Distribution Pattern:

AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, Luxembourg, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated