—#142934

Product

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 product code: OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K132582
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: US distribution in the state of FL and PA.

Timeline

Recall initiated: 2015-09-28
Posted by FDA: 2016-02-13
Terminated: 2017-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142934. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.