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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/
Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Mr. Timothy Huntington
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.