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.
FDA Recall Z-0809-2016 · Posted 2016-02-13
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Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeOVE
Date Initiated2015-09-28
Date Terminated2017-03-01
Product Quantity19 pieces
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)
Firm 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 [email protected] or 1-800-392-2832
Root Cause
Process control
Distribution Pattern
US distribution in the state of FL and PA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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