CLASS I Device recall · Reported 31 May 2017 · FDA Enforcement Report
10-1398M - SpF-PLUS Implantable Stimulator recalled by EBI Patient Care
EBI Patient Care is recalling 10-1398M - SpF-PLUS Implantable Stimulator, distributed nationwide in the US. The recall was initiated on 20 Apr 2017 and the FDA has classified it as Class I.
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-2119-2017
- FDA event ID
- 77089
- Recalling firm
- EBI Patient Care, Guaynabo, PR
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Apr 2017
- FDA classified
- 25 May 2017
- Reported
- 31 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 20 Apr 2017 | Recall initiated by company | |
| 25 May 2017 | Classified by FDA | +35 days |
| 31 May 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
Product as listed by the FDA
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Where it was distributed
Nationwide distribution only.
Questions about this recall
Is 10-1398M - SpF-PLUS Implantable Stimulator recalled?
Yes. EBI Patient Care recalled 10-1398M - SpF-PLUS Implantable Stimulator on 20 Apr 2017. The recall is Class I and its status is Terminated. Recall number Z-2119-2017.
Why was it recalled?
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
Which lots are affected?
Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.
Where was it sold?
Nationwide distribution only.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 EBI Patient Care
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator recalled | EBI Patient Care | Other | 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 |