Centinel Spine, Inc. recalls prodisc C SK, Total cervical disc replacement, medical devi
Recalled Product
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Hazard / Issue
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.
Issued by
FDA
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