FDA Device recall Z-0809-2016
Exactech Acapella One Interbody Fusion Device Parallel
- FDA Device
- Class II
- terminated
- Published 2016-02-24
On 2016-02-24 the FDA classified a Class II recall of Exactech Acapella One Interbody Fusion Device Parallel by Exactech, citing 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 On….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0809-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-28 |
| Published | 2016-02-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | FL, PA |
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
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)
Identifiers
| code_info | Catalog # 05-090-02-1610 // Expiration 07/2023 Serial #'s: 4053365, 4053366, 4053367, 4053368, 4053369, 4053370, 40533…Catalog # 05-090-02-1610 // Expiration 07/2023 Serial #'s: 4053365, 4053366, 4053367, 4053368, 4053369, 4053370, 4053371, 4053372, 4053373, 4053374, 4053375, 4053376, 4053377, 4053378, 4053379, 4053380, 4053381, 4053382, and 4053383 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0809-2016%22
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