prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Summary
The FDA issued a Class II for prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Nu by Centinel Spine, Inc.. Reason: During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that m.
Details
Source
Device Recall
External ID
Z-3212-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
Product Description
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Lot/Code Info: UDI-DI 00843193113856; Lot 2024-0482
Quantity Affected: 12 units
Reason for Recall
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-18
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 244 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-3212-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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