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.
This recall has been terminated (originally issued April 7, 2020).
- Company
- Innovasis, Inc
- Recall Initiated
- April 7, 2020
- Terminated
- January 26, 2022
- Recall Number
- Z-2062-2020
- Quantity
- 6
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution including in the states of CA, AL, LA.
Lot / Code Info
Serial numbers: 2339, 2340, 2346, 2351, 2352, 2354,
Root Cause
Process control
Action Taken
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