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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Anterior Cervical Distraction Pin

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  Class 2 Device Recall Medline Anterior Cervical Distraction Pin see related information
Date Initiated by Firm December 14, 2016
Create Date May 17, 2017
Recall Status1 Terminated 3 on July 09, 2019
Recall Number Z-2103-2017
Recall Event ID 76298
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA
Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
Code Information Item# MDS9091616T; Lot #132638
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES INC
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Kassandra Cotner
847-643-3245
Manufacturer Reason
for Recall		 Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
FDA Determined
Cause 2		 Process control
Action Medline Industries sent an Immediate Action Required letter dated December 14, 2016, to all affected customers with response forms via US mail, notifying them of the recall. Customers were instructed to quarantine affected product and return it to the firm. The product will be repackaged and sterilized. Customers with questions were instructed to call 866-359-1704. For questions regarding this recall call 847-643-3245.
Quantity in Commerce 198 individual packs
Distribution Nationwide Distribution
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.
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