Class 2 Device Recall Oryx Cervical Plate System

• Date Initiated by Firm: April 07, 2020
• Create Date: May 20, 2020
• Recall Status: Terminated on January 26, 2022
• Recall Number: Z-2062-2020
• Recall Event ID: 85575
• 510(K)Number: K192049
• Product Classification: Appliance, fixation, spinal intervertebral body - Product Code KWQ
• Product: Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.
• Code Information: Serial numbers: 2339, 2340, 2346, 2351, 2352, 2354,
• Recalling Firm/ Manufacturer: Innovasis, Inc; 614 E 3900 S; Salt Lake City UT 84107-1902
• Manufacturer Reason for Recall: Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled as "Variable" should be labeled as "Fixed. If user installs a fixed rescue screw instead of variable, the screw head may not be flush, it could back out, which could interfere with the cover screw.
• FDA Determined Cause: Process control
• Action: On 04/07/202, the firm emailed the "URGENT: ADVISORY NOTICE", to consignees informing them of their plan to correct this issue with a three-step approach: 1) Make the consignee aware of the issue. Further, consignees were asked to notify any necessary case reps and/or surgeon users who may need to understand this distinction in the next week, before the firm issues a temporary fix. 2) The firm is initiating the following "temporary fix": Future orders will include reworked caddies with the words "FIXED" and "VARIABLE" removed. By doing this, the default organization is by color and by laser marking on the parts themselves. Fixed screws can be identified by the color (gold) or the first letters of the Part No. on the screw head (APF). Variable screws can be identified by the green color or by Part No. starting with APV. If/when you receive one of these temporary caddies, please pull the screws out of your current caddies and place them in one of the temporary caddies and return the incorrect caddy. Our Customer Service department will provide return shipping labels as necessary. 3) Another recall letter will follow requesting that consignees swap screws from temporary caddies into the correct caddies, and return temporary caddies. On 04/13/2020, the firm emailed "'URGENT: MEDICAL DEVICE RECALL" notices and Response Forms to consignees. The firm is issuing a "temporary Fix": Future orders will include reworked caddies with the words "FIXED" and "VARIABLE" corrected by way of laser engraving. These caddies will be in a conforming state. Upon receiving one of these reworked caddies, please pull the screws out of your current (non-conforming) caddies and place them in one of the reworked (conforming) caddies and return the original non-conforming caddy. The firm will be ordering new caddies that will then be swapped out with the reworked caddies. The firm requests consignees complete and return Product Removal Forms. Product Removal Forms will indicate ho
• Quantity in Commerce: 6
• Distribution: US Nationwide distribution including in the states of CA, AL, LA.
• 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.

• 510(K) Database: 510(K)s with Product Code = KWQ and Original Applicant = Innovasis, Inc.