Drug recall
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
FDA recall event 95164 · Class II · Centinel Spine, Inc.
Key facts
| Event ID | 95164 |
|---|---|
| Recall numbers | Z-3212-2024, Z-3213-2024 |
| Recalling firm | Centinel Spine, Inc. |
| Product type | Devices |
| Products | prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5, prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 18, 2024 |
| Report date | Oct 2, 2024 |
| City | West Chester |
| State | PA |
| Country | United States |
| FEI number | 3007494564 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: