prodisc C SK, Total cervical disc replacement, medical d... (Centinel Spine, Inc.) – during the assembly of prodisc c, a b... (2024)
An unidentified discoloration may potentially indicate a manufacturing quality issue.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Brand
Centinel Spine, Inc.
Lot Codes / Batch Numbers
UDI-DI 00843193113856, Lot 2024-0482
Products Sold
UDI-DI 00843193113856; Lot 2024-0482
Centinel Spine, Inc. is recalling prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5 due to During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Customers were contacted via telephone beginning 7/18/24. The Centinel Quality team has identified a potential nonconformance on three specific lots in the prodisc c product family. We are requesting the return of the inventory that is assigned to you. We will provide replacement inventory proactively to support the business. Thank you for your support. In addition, an URGENT - MEDICAL DEVICE Recall Instructions for PRODISC C IMPLANTS notification letter was sent to the distributor. Required Action: Please retrieve the identified devices and return the affected devices to Centinel Spine Depth of Recall: This recall should be carried out to the hospital level, including Distributors and Consigned locations Please acknowledge that you have read the email and enable the Return Receipt. This is necessary to ensure traceability as part of the recall process. If you have any questions, please contact Jessica Staub 484.887.8803.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026