FDA-Device2026-02-25Class IIMISBRANDING
Centinel Spine Prodisc C SK cervical disc replacement recalled for mislabeling
LABEL MIX UPNationwide distribution
Contact Centinel Spine about Prodisc C SK disc replacement
Centinel Spine's Prodisc C SK cervical disc replacement devices were labeled as 6mm but actually contained 5mm products. This mislabeling affects 20 units distributed across eight states. The size difference could affect surgical fit and patient outcomes.
- If you received a Prodisc C SK device (Model PDSL6, Lot 2025-0776), contact Centinel Spine immediately
- Do not use the device until you verify the actual size with the manufacturer
- Contact your surgeon or hospital if you have already received this implant
Hazard
Products were mislabeled as the 6mm product but included the 5 mm product.
Sold states
US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
Affected count
20 units
Manufactured in
900 Airport Rd Ste 3b, West Chester, PA, United States
Products
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1426-2026Don't want to check this manually?
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