CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
prodisc C SK, Total cervical disc replacement recalled by Centinel Spine
Centinel Spine is recalling prodisc C SK, Total cervical disc replacement, distributed nationwide in the US. The recall was initiated on 18 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3213-2024
- FDA event ID
- 95164
- Recalling firm
- Centinel Spine, West Chester, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jul 2024
- FDA classified
- 24 Sep 2024
- Reported
- 2 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 18 Jul 2024 | Recall initiated by company | |
| 24 Sep 2024 | Classified by FDA | +68 days |
| 2 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot Code: UDI-DI 00843193113856; Lot 2024-0482
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95164This product is part of a recall event; the main page for the event is prodisc C SK, Total cervical disc replacement, medical device recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | prodisc C SK, Total cervical disc replacement, medical device recalled | Centinel Spine | Device Malfunction | Nationwide |
More recalls from Centinel Spine
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Prodisc C SK U.S. Implant Extra Large recalled by Centinel Spine | Centinel Spine | Other | Nationwide |
| Device | CLASS II | Prodisc C SK U.S. Implant Extra Large recalled by Centinel Spine | Centinel Spine | Other | Nationwide |
| Device | CLASS II | Prodisc C SK recalled by Centinel Spine | Centinel Spine | Labeling Errors | Nationwide |
| Device | CLASS II | prodisc C SK, Total cervical disc replacement, medical device recalled | Centinel Spine | Device Malfunction | Nationwide |
| Device | CLASS II | Prodisc C - prosthesis, intervertebral disc recalled by Centinel Spine | Centinel Spine | Packaging Defects | Nationwide |
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| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
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| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
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| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |