prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
- Company
- Centinel Spine, Inc.
- Recall Initiated
- July 18, 2024
- Posted
- September 24, 2024
- Recall Number
- Z-3213-2024
- Quantity
- 6 units
- Firm Location
- West Chester, PA
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.
Distribution
US Nationwide distribution.
Lot / Code Info
Lot Code: UDI-DI 00843193113856; Lot 2024-0482
Root Cause
Process control
Action Taken
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.