Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Prodisc C - prosthesis Recalled by Centinel Spine, Inc. Due to Centinel Spine learned through five customer complaints that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Centinel Spine, Inc. directly.
Affected Products
Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S
Quantity: 49 devices
Why Was This Recalled?
Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Centinel Spine, Inc.
Centinel Spine, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report