Z-0809-2016 Class II Terminated
FDA device recall Z-0809-2016 was initiated by Exactech, Inc. on Sep 28, 2015 and is designated Class II. 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… The recall status is terminated (terminated Mar 1, 2017). Affected quantity: 19 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 24, 2016
- Initiation Date
- Sep 28, 2015
- Termination Date
- Mar 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 pieces
Product Description
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)
Distribution Pattern
US distribution in the state of FL and PA.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0809-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026