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 | Shipped to a single consignee prior to completion of final inspection. |
| Product | Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. |
| Quantity | 4 devices. |
| Distribution | Nationwide Distribution to Florida only. |
| Initiated | 2015-05-21 |
| Classified | 2015-07-14 |
| Terminated | 2015-07-16 |
| Recall number | Z-2070-2015 |
| 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-2070-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71501/
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