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 | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. |
| Product | Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 |
| Quantity | 98 |
| Distribution | AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland. |
| Initiated | 2016-11-07 |
| Classified | 2017-01-17 |
| Terminated | 2019-08-05 |
| Recall number | Z-1032-2017 |
| 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-1032-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75989/
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