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U.S. Department of Health and Human Services

Class 2 Device Recall Cervical Plate

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  Class 2 Device Recall Cervical Plate see related information
Date Initiated by Firm May 21, 2015
Date Posted July 14, 2015
Recall Status1 Terminated 3 on July 16, 2015
Recall Number Z-2070-2015
Recall Event ID 71501
510(K)Number K142576  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Exactech Ambassador Cervical Plate System
The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Code Information Catalog Number 05-100-03-0042, Lot # 68122001.
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		 Shipped to a single consignee prior to completion of final inspection.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action Exactech contacted their consignee by telephone on May 21, 2015, of this recall for their two products and instructed him to recover the devices from the hospital. Devices were recovered from the hospital May 22, 2015, and returned to the firm on May 26. All devices have been recovered.
Quantity in Commerce 4 devices.
Distribution Nationwide Distribution to Florida only.
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 = KWQ and Original Applicant = EISERTECH, LLC
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