Recall Z-3213-2024 ยท MJO Prosthesis, Intervertebral Disc
Centinel Spine, Inc.
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
| Date | Sep 24, 2024 (initiated Jul 18, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 6 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.