Class II
Medical Device Recall: prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Centinel Spine, Inc. · July 18, 2024
Reason for Recall
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
12 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3212-2024
Status: ongoing
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