Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Summary
The FDA issued a Class II for Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervic by Centinel Spine, Inc.. Reason: 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 prod.
Details
Source
Device Recall
External ID
Z-2051-2026
Action Date
2026-05-13
Status
Ongoing
Category
device
Product Description
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Lot/Code Info: Model Number: PDSXL6; UDI-DI: 00843193113986; Lot Number: 2026-0027
Quantity Affected: 30 units
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.
Distribution
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-20
Company
West Chester, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 250 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Centinel Spine, Inc. has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Centinel Spine, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Centinel Spine, Inc. have FDA actions?
Centinel Spine, Inc. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2051-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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