Cervical disc replacement recalled for foreign contamination in assembly
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
- Product
- prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
- Category
- Medical Device
- Distribution
- Distributed nationwide