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
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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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