10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries,...
FDA Recall #Z-2105-2017 — Class II — December 14, 2016
Product Description
10 mm Distraction Pin, Aggressive 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.
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.
Recalling Firm
MEDLINE INDUSTRIES INC — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
49 individual packs
Distribution
Nationwide Distribution
Code Information
Item# MDS9091010; Lots #133115, 136754
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated