Recall Z-2062-2020 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Innovasis, Inc
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.
| Date | Apr 7, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root 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 |
| Quantity | 6 |
| Distribution | US Nationwide distribution including in the states of CA, AL, LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192049 | Oryx Cervical Plate System Innovasis, Inc., Nov 8, 2019 |