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U.S. Department of Health and Human Services

Class 2 Device Recall UniVise Inserter

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  Class 2 Device Recall UniVise Inserter see related information
Date Initiated by Firm September 08, 2015
Date Posted November 05, 2015
Recall Status1 Terminated 3 on January 14, 2019
Recall Number Z-0222-2016
Recall Event ID 72495
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Code Information Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Mr. Timothy Huntington
201-760-8346
Manufacturer Reason
for Recall		 The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
FDA Determined
Cause 2		 Process control
Action Stryker Spine issued an "Urgent Product Removal Notifications /Customer Response Forms dated September 11, 2015. to all affected customers via Fed Ex priority overnight. The notification instructed customers on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Customers were asked to examine their inventory and related hospital location inventories; and reconcile any UniVise Inserters with Catalog numbers and Lot numbers (referenced in the notification). Customers were asked to fax a copy of the Customer Response Form to Regulatory Compliance (at 855-632-9049) or email it to Spine-RegulatoryActions@Stryker.com within 5 days of receipt of the notification. For further questions please call (201) 760-8346.
Quantity in Commerce 41 units
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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