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.
Enforcement
- Recall Number
- Z-0809-2016
- Event ID
- 73057
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Exactech, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 24, 2016
- Initiation Date
- September 28, 2015
- Classification Date
- February 12, 2016
- Termination Date
- March 1, 2017
- Address
- 2320 NW 66th Ct, Gainesville, FL, 32653-1630, United States
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.
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)
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
US distribution in the state of FL and PA.
19 pieces