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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech Spine, Large Set Screw

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  Class 2 Device Recall Exactech Spine, Large Set Screw see related information
Date Initiated by Firm March 06, 2009
Date Posted July 10, 2015
Recall Status1 Terminated 3 on July 14, 2015
Recall Number Z-2059-2015
Recall Event ID 71528
510(K)Number K051216  
Product Classification Orthosis, spondylolisthesis spinal fixation - Product Code MNH
Product Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107.

Intended to provide immobilization and stabilization of spinal segments.
Code Information Catalog Number 28202, Lot Number AS05107
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Graham L Cuthbert
352-377-1140
Manufacturer Reason
for Recall		 Incorrect thread form on the screw.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified with a Product Recall Notice on 03/06/2009 that all screws must be checked to ensure that any discrepant products to be removed from the field.
Quantity in Commerce 749 devices
Distribution Distributed in the states of FL, GA, IL, NY, TX, and WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MNH and Original Applicant = ALTIVA CORP.
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