Z-3212-2024Class II

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

Name: Z-3212-2024 prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Creator: Centinel Spine, Inc.
Published: 2024-07-18
License: https://open.fda.gov/license/

Centinel Spine, LLC / initiated 2024-07-18 / Open, Classified / root cause: manufacturing process

FDA source

Centinel Spine, Inc. began a recall of prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5 on 2024-07-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3212-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-18
Posted: 2024-09-24
Recalling firm: Centinel Spine, LLC
Product: prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Product code: MJO Prosthesis, Intervertebral Disc
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 12 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI 00843193113856; Lot 2024-0482

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3212-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3212-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24
Z-3213-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24

Product code MJO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)