CLASS II Device recall · Reported 21 Apr 2021 · FDA Enforcement Report
Prodisc C - prosthesis, intervertebral disc recalled by Centinel Spine
Centinel Spine is recalling Prodisc C - prosthesis, intervertebral disc, distributed nationwide in the US. The recall was initiated on 5 Mar 2021 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-1406-2021
- FDA event ID
- 87530
- Recalling firm
- Centinel Spine, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2021
- FDA classified
- 9 Apr 2021
- Reported
- 21 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Spinal Implants
Timeline
| 5 Mar 2021 | Recall initiated by company | |
| 9 Apr 2021 | Classified by FDA | +35 days |
| 21 Apr 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S
Where it was distributed
US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI.
Nationwide ArizonaCaliforniaColoradoDistrict of ColumbiaFloridaGeorgiaKentuckyMarylandMichiganNorth CarolinaNew YorkOhioPennsylvaniaTennessee
Questions about this recall
Is Prodisc C - prosthesis, intervertebral disc recalled?
Yes. Centinel Spine recalled Prodisc C - prosthesis, intervertebral disc on 5 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1406-2021.
Why was it recalled?
Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.
Which lots are affected?
UDI (01)00843193112842(17)241231(10)2020-0600 Lot number: 2020-0600
Where was it sold?
US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Centinel Spine
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Prodisc C SK U.S recalled by Centinel Spine | Centinel Spine | Other | Nationwide |
| Device | CLASS II | Prodisc C SK U.S 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 recalled by Centinel Spine | Centinel Spine | Device Malfunction | Nationwide |
| Device | CLASS II | prodisc C SK, Total cervical disc replacement, medical device recalled | Centinel Spine | Device Malfunction | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |