Z-3213-2024 Class II Ongoing
FDA device recall Z-3213-2024 was initiated by Centinel Spine, Inc. on July 18, 2024 and is designated Class II. 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 manufactur… The recall status is ongoing. Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- July 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
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 Pattern
US Nationwide distribution.
Code Information
Lot Code: UDI-DI 00843193113856; Lot 2024-0482