Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. M

FDA device recall Z-0222-2016 · posted 2015-11-05 · Terminated

Recall details

Recalling firm

Stryker Spine

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.

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.

Root cause

Process control

Status

Terminated

Product code

LXH

Quantity affected

41 units

Distribution

Nationwide Distribution.

Date initiated

2015-09-08

Date posted

2015-11-05

Date terminated

2019-01-14

Location

Allendale, NJ