Centinel Spine, Inc. recalls prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
- Recall date
- July 18, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3213-2024
- FDA classification
- Class II
- Brand / firm
- Centinel Spine, Inc.
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
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