EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer — Class II medical device recall Z-2666-2017
Terminated recall by Exactech, Inc., reported 2017-07-12, distributed in AL, AZ, CA, CO, CT, FL, GA, HI…. Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid,
| Recall number | Z-2666-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2017-05-25 |
| Classified | 2017-07-03 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2019-07-26 |
| Distributed | 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 |
| Countries outside the US | AT, AU, BR, CA, CH, CN, DE, ES, FR, GB, GR, IN, IT, KR, LU, NL, SE, SG, ZA |
| Quantity | 2,069 |
| Reason classes | device malfunction |
| Model numbers | 321-25-38, 321-25-42, 321-25-46 |
Product
EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2666-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.