Reported Oct 2, 2024 · Ongoing
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Centinel Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Centinel Spine, Inc. · 900 Airport Rd Ste 3b · West Chester, PA · 19380-3416
Is this the product you have?
- prodisc C SK, Total cervical disc replacement, medical device
- Model/Catalog NumberPDSM5
- Lot codes and dates
UDI-DI 00843193113856Lot 2024-0482
- Amount recalled
- 12 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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