CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report

Prodisc C SK recalled by Centinel Spine

Centinel Spine is recalling Prodisc C SK, distributed nationwide in the US. The recall was initiated on 31 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;

Quantity recalled20 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-1426-2026
FDA event ID: 98282
Recalling firm: Centinel Spine, West Chester, PA
Classification: Class II
Status: Ongoing
Recall initiated: 31 Dec 2025
FDA classified: 17 Feb 2026
Reported: 25 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Medical Software

Timeline

31 Dec 2025	Recall initiated by company
17 Feb 2026	Classified by FDA	+48 days
25 Feb 2026	Published in enforcement report	+8 days

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

Reason for recall

Products were mislabeled as the 6mm product but included the 5 mm product.

Product as listed by the FDA

Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

Where it was distributed

US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.

Nationwide Alabama California Colorado Louisiana New York Oregon Tennessee Texas

Questions about this recall

Is Prodisc C SK recalled?

Yes. Centinel Spine recalled Prodisc C SK on 31 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1426-2026.

Why was it recalled?

Products were mislabeled as the 6mm product but included the 5 mm product.

Which lots are affected?

Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;

Where was it sold?

US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Centinel Spine

All 6

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