United StatesProdisc C SK U.S. IMPLANT EXTRA LARGE 5MM (Model PDSXL5, UDI-DI 00843193113979, Lot 2026-0026) and Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM (Model PDSXL6, UDI-DI 00843193113986, Lot 2026-0027) are affected. The devices were recalled due to a product labeling mix up in which the 6mm device was labeled as 5mm and the 5mm device was labeled as 6mm. Thirty units were distributed nationwide in AZ, CA, GA, LA, MO, NY, TN, and TX.
What's being recalled
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Recalling firm: Centinel Spine, Inc., West Chester, PA, United States.
How to identify it
Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026 Model Number: PDSXL6; UDI-DI: 00843193113986; Lot Number: 2026-0027
The hazard
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
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 AZ, CA, GA, LA, MO, NY, 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)