FDA Enforcement
Class II
Ongoing
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Recall: Z-3212-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3212-2024
- Event ID
- 95164
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Centinel Spine, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- October 2, 2024
- Initiation Date
- July 18, 2024
- Classification Date
- September 24, 2024
- Address
- 900 Airport Rd Ste 3b, West Chester, PA, 19380-3416, United States
Description
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
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.
Code Info
UDI-DI 00843193113856; Lot 2024-0482
Distribution
US Nationwide distribution.
Quantity
12 units