FDA-Device2024-10-02Class II
prodisc C SK, Total cervical disc replacement, 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
6 units
Manufactured in
900 Airport Rd Ste 3b, West Chester, PA, United States
Products
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3213-2024Don't want to check this manually?
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