Class II — Exactech, Inc.
| Recalling firm | EXACTECH, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device. |
| Product | Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component. |
| Quantity | 112 devices |
| Distribution | Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada. |
| Initiated | 2015-02-13 |
| Classified | 2015-04-20 |
| Terminated | 2016-09-29 |
| Recall number | Z-1459-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Exactech, Inc. (Z-1459-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70722/
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