CLASS II Device recall · Reported 30 Mar 2016 · FDA Enforcement Report
Instinct¿ Java¿ System (IFU reference recalled by Zimmer Spine
Zimmer Spine is recalling Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral, distributed nationwide in the US. The recall was initiated on 12 Feb 2016 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-1190-2016
- FDA event ID
- 73363
- Recalling firm
- Zimmer Spine, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Feb 2016
- FDA classified
- 18 Mar 2016
- Reported
- 30 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 12 Feb 2016 | Recall initiated by company | |
| 18 Mar 2016 | Classified by FDA | +35 days |
| 30 Mar 2016 | 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
Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universal Clamp¿ System (IFU reference: SNA027-N-90001).
Product as listed by the FDA
Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.
Where it was distributed
US (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIdahoIllinoisIndianaLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew HampshireNevada
Questions about this recall
Is Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral recalled?
Yes. Zimmer Spine recalled Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral on 12 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1190-2016.
Why was it recalled?
Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universal Clamp¿ System (IFU reference: SNA027-N-90001).
Which lots are affected?
All lots
Where was it sold?
US (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.
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 Zimmer Spine
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Universal Clamp¿ System (IFU reference: SNA027-N-90001) recalled | Zimmer Spine | Potency & Assay | Nationwide |
| Device | CLASS II | Virage OCT Spinal Fixation System recalled by Zimmer Spine | Zimmer Spine | 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 |