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Recall Observatory FDA recall evidence

Device product

prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5

Z-3213-2024

July 18, 2024

Class II

Product summary

Firm
Centinel Spine, Inc.
Event
Event 95164
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-3213-2024

Official wording

Reason: 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.

Code information: Lot Code: UDI-DI 00843193113856; Lot 2024-0482

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.