Recall Z-3212-2024— Centinel Spine, Inc.
Class II · Ongoing
Class II FDA medical device recall by Centinel Spine, Inc., initiated 2024-07-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Centinel Spine, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-18
- Firm location
- West Chester, PA, United States
Product description
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.