Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
FDA Recall Z-0222-2016 · Posted 2015-11-05
Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeLXH
Date Initiated2015-09-08
Date Terminated2019-01-14
Product Quantity41 units
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.
Firm 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 [email protected] within 5 days of receipt of the notification.
For further questions please call (201) 760-8346.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.