Z-2665-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2017
- Initiation Date
- May 25, 2017
- Termination Date
- July 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 928
Product Description
EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
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.
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
Code Information
All Lots