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U.S. Department of Health and Human Services

Class 2 Device Recall Mac Pin NonCannulated Screw

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  Class 2 Device Recall Mac Pin NonCannulated Screw see related information
Date Initiated by Firm July 07, 2017
Create Date January 10, 2018
Recall Status1 Terminated 3 on October 15, 2019
Recall Number Z-0325-2018
Recall Event ID 77991
510(K)Number K153152  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Code Information Model #85-6560-1, Lot #132117
Recalling Firm/
Manufacturer		 Amendia, Inc
1755 W Oak Pkwy
Marietta GA 30062-2260
For Additional Information Contact
770-575-5224
Manufacturer Reason
for Recall		 Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
FDA Determined
Cause 2		 Process control
Action Customers were sent recall notification letters on 07/07/2017. Instructions included to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia, and to complete and return the questionnaire. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.
Quantity in Commerce 41 screws
Distribution Distribution to Georgia, USA.
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 = NKB and Original Applicant = AMENDIA, INC.
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