Innovasis recalls Oryx Cervical Screw Caddy Model BTA-172 due to incorrect labeling of fixed and variable rescue screws, which could cause improper installation and interference with cover screws.
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.
Innovasis is recalling Oryx Cervical Screw Caddy Model BTA-172 because the labels for fixed and variable rescue screws are swapped. If users install the wrong screw type, it may not sit flush and could back out, interfering with the cover screw and potentially causing complications during spinal surgery.
The caddy labels for 4.5mm Fixed and Variable rescue screws are incorrect. If a surgeon installs a Fixed screw where a Variable one is needed, the screw head may not be flush with the plate. This could cause the screw to back out, leading to interference with the cover screw and potential complications during spinal fusion procedures.
Patients undergoing spinal surgery using the Oryx Cervical Plate System with this specific screw caddy model are affected. Surgeons and surgical teams using the product are most at risk.
Check for the model number BTA-172 on the Oryx Cervical Screw Caddy. The affected units have serial numbers 2339, 2340, 2346, 2351, 2352, and 2354.
Verify that the caddy labels correctly identify the screw types as 'Variable' for the location that should hold fixed screws and 'Fixed' for the location that should hold variable screws.
The caddy labels for 4.5mm Fixed and Variable rescue screws are swapped. If a surgeon installs a Fixed screw where a Variable one is needed, the screw head may not be flush and could back out, interfering with the cover screw.
The affected model is BTA-172 with serial numbers 2339, 2340, 2346, 2351, 2352, and 2354.
The recall record does not specify a remedy. Users should check the labels to ensure correct screw installation.
We’ve drafted a message you can send Innovasis to request your refund or repair — edit it as you like.
Subject: Recall Z-2062-2020 — Innovasis Innovasis Hello, I own a Innovasis that is covered by recall Z-2062-2020 from Innovasis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
