FDA Medical Device Recalls (openFDA)
Centinel Spine, Inc.: prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
- Recall number
- Z-3213-2024
- Recalling firm
- Centinel Spine, Inc.
- Product
- prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
- Status
- Open, Classified
- Initiated
- 2024-07-18
- Posted
- 2024-09-24
- Terminated
- not on file
- 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.
- 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
- 6 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Code: UDI-DI 00843193113856; Lot 2024-0482
- 510(k) numbers
- not on file
- PMA numbers
- ["P070001S019"]
- Product code
- MJO
- Firm FEI
- 3007494564
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28