CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

Prodisc C SK U.S. Implant Extra Large recalled by Centinel Spine

Centinel Spine is recalling Prodisc C SK U.S. Implant Extra Large, distributed nationwide in the US. The recall was initiated on 20 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026

Quantity recalled30 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2050-2026
FDA event ID: 98721
Recalling firm: Centinel Spine, West Chester, PA
Classification: Class II
Status: Ongoing
Recall initiated: 20 Mar 2026
FDA classified: 1 May 2026
Reported: 13 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Mar 2026	Recall initiated by company
1 May 2026	Classified by FDA	+42 days
13 May 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

Where it was distributed

US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.

Nationwide Arizona California Georgia Louisiana Missouri New York Tennessee Texas

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026

Where was it sold?

US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98721

Reported	Class	Recall	Company	Reason	Where
13 May 2026	CLASS II	Prodisc C SK U.S. Implant Extra Large recalled by Centinel Spine	Centinel Spine	Other	Nationwide

More recalls from Centinel Spine

All 6

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS II	Prodisc C SK U.S. Implant Extra Large recalled by Centinel Spine	Centinel Spine	Other	Nationwide
25 Feb 2026Device	CLASS II	Prodisc C SK recalled by Centinel Spine	Centinel Spine	Labeling Errors	Nationwide
2 Oct 2024Device	CLASS II	prodisc C SK, Total cervical disc replacement recalled by Centinel Spine	Centinel Spine	Device Malfunction	Nationwide
2 Oct 2024Device	CLASS II	prodisc C SK, Total cervical disc replacement, medical device recalled	Centinel Spine	Device Malfunction	Nationwide
21 Apr 2021Device	CLASS II	Prodisc C - prosthesis, intervertebral disc recalled by Centinel Spine	Centinel Spine	Packaging Defects	Nationwide

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