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.
Recall
- Recall Number
- Z-0809-2016
- Event Number
- 73057
- Firm
- Exactech, Inc.
- FEI Number
- 1038671
- Product Code
- OVE
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- September 28, 2015
- Posted
- February 13, 2016
- Terminated
- March 1, 2017
- Address
- 2320 NW 66th Ct, Gainesville, FL, 32653-1630
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)
Exactech sent a recall notification letter dated September 28, 2016 to their only 2 consignees. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately cease distribution or use of these products, extend this information to accounts that have this products in their possession, identify and quarentine any of the product and complete and return the attached recall inventory response form to Exactech. Contact: Kaya Davis at [email protected] or 1-800-392-2832
US distribution in the state of FL and PA.
19 pieces