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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech Acapella One Interbody Fusion Device Parallel

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 Class 2 Device Recall Exactech Acapella One Interbody Fusion Device Parallel see related information
Date Posted February 13, 2016
Recall Status1 Open
Recall Number Z-0809-2016
Recall Event ID 73057
510(K)Number K132582 
Product Classification Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
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.
Code Information 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
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Kaya Davis
800-392-2832
Manufacturer 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)
FDA Determined
Cause 2
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 in Commerce 19 pieces
Distribution US distribution in the state of FL and PA.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OVE and Original Applicant = EXACTECH, INC.
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