United StatesThe Prodisc C SK total cervical disc replacement (Brand: Prodisc; Model/Catalog PDSL6; UDI‑DI 00843193113924; Lot 2025-0776) is being recalled. Units were mislabeled as the 6 mm product but actually included the 5 mm implant; 20 units were distributed in AL, CA, CO, LA, NY, OR, TN and TX.
What's being recalled
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Recalling firm: Centinel Spine, Inc., West Chester, PA, United States.
How to identify it
Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;
The hazard
Products were mislabeled as the 6mm product but included the 5 mm product.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)