Exactech Acapella One Interbody Fusion Device Parallel — Class II medical device recall Z-0809-2016
Terminated recall by Exactech, Inc., reported 2016-02-24, distributed in FL, PA. Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody
| Recall number | Z-0809-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2015-09-28 |
| Classified | 2016-02-12 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2017-03-01 |
| Distributed | FL, PA |
| Quantity | 19 units |
| Reason classes | labeling |
| Serial numbers | 4053365, 4053366, 4053367, 4053368, 4053369, 4053370, 4053371, 4053372, 4053373, 4053374, 4053375, 4053376, 4053377, 4053378, 4053379, 4053380, 4053381, 4053382, 4053383 |
| Model numbers | 05-090-02-1610 |
| Expiration dates | 2023-07 |
Product
Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.
Reason for recall
Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One Interbody Fusion Device Parallel (05-090-02-1610)
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-0809-2016. 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.