Centinel Spine, Inc. recalls Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
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.
Read the official notice →- Date
- 2026-05-13
- Country
- United States
- Brand
- Centinel Spine
- Product
- Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Centinel Spine recalls
- 2026-02-25
USCentinel Spine, Inc. recalls Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc…
Products were mislabeled as the 6mm product but included the 5 mm product.
FDA · DeviceCentinel Spine, Inc.US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.Official notice →- 2024-10-02
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Centinel Spine, Inc. recalls prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
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