Prodisc C SK recallZ-3212-2024 · Centinel Spine, Inc. · initiated Jul 18, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Centinel Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-3212-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 18, 2024
- Posted by the FDA
- Sep 24, 2024
- Recalling firm
- Centinel Spine, Inc.
- Quantity
- 12 units
- Product code
- MJO
- FDA submissions
- P070001S019
- Distribution
- US Nationwide distribution.
Product description
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Code information (models, lots, serial numbers)
UDI-DI 00843193113856; Lot 2024-0482
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Prodisc C SK PDSM5Centinel Spine, LLC · Prosthesis, Intervertebral Disc2 recalls4 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 95164).
- Z-3213-2024 · Open, Classifiedprodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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