Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
prodisc C SK Recalled by Centinel Spine, Inc. Due to During the assembly of Prodisc C, a blue...
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 SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
Quantity: 6 units
Why Was This Recalled?
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
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