FDAFDA · Food and drugs·Recall number Z-3212-2024
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Published October 2, 2024 · Recall initiated: July 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Centinel Spine, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI 00843193113856; Lot 2024-0482
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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