prodisc C SK recall: Contamination
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Why was prodisc C SK recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00843193113856; Lot 2024-0482
- Product
- prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
- Recalling firm
- Centinel Spine, Inc.
- Quantity
- 12 units
- Distribution
- US Nationwide distribution.
- Recall date
- October 2, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)