FDA Device recall Z-2663-2017
EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
- FDA Device
- Class II
- terminated
- Published 2017-07-12
On 2017-07-12 the FDA classified a Class II recall of EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01 by Exactech, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2663-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-25 |
| Published | 2017-07-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI |
Product
EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
Reason
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.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2663-2017%22
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