FDA-Device2024-10-02Class II
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Centinel Spine, Inc.
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.
Sold states
US Nationwide distribution.
Affected count
12 units
Manufactured in
900 Airport Rd Ste 3b, West Chester, PA, United States
Products
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3212-2024Don't want to check this manually?
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