Centinel Spine, Inc. 2026-05-13 Health serious FDA
Health · FDA · Recall #FDA-Z-2050-2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc… Recall
Issued May 13, 2026 · Centinel Spine, Inc.
In May 2026, Centinel Spine, Inc. recalled the Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Centinel Spine, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Centinel Spine, Inc.
- Category
- Health
- Recall date
- May 13, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
- Recall number
- FDA-Z-2050-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Centinel Spine, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.