Oryx Cervical Screw Caddy recall
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…
Why was Oryx Cervical Screw Caddy recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers: 2339, 2340, 2346, 2351, 2352, 2354,
- 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…
- Recalling firm
- Innovasis, Inc
- Quantity
- 6
- Distribution
- US Nationwide distribution including in the states of CA, AL, LA.
- Recall date
- May 27, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)