Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
- Company
- Stryker Spine
- Recall Initiated
- September 8, 2015
- Posted
- November 5, 2015
- Terminated
- January 14, 2019
- Recall Number
- Z-0222-2016
- Quantity
- 41 units
- Firm Location
- Allendale, NJ
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.
Root Cause
Process control
Action Taken
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.