Recall Z-0809-2016 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Exactech, Inc.
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
| Date | Feb 13, 2016 (initiated Sep 28, 2015) |
| Status | Terminated |
| 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) |
| Root cause | Process control |
| Action | 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 Kaya@exac.com or 1-800-392-2832 |
| Quantity | 19 pieces |
| Distribution | US distribution in the state of FL and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132582 | EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM Exactech, Inc., Feb 12, 2014 |