CLASS II Device recall · Reported 18 Sep 2013 · FDA Enforcement Report
StaXx¿ IB Convex Expandable Implant recalled by Spine Wave
Spine Wave is recalling StaXx¿ IB Convex Expandable Implant, Intervertebral Fusion Device, Lumbar, distributed in Florida, Oregon. The recall was initiated on 14 May 2013 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-2187-2013
- FDA event ID
- 65968
- Recalling firm
- Spine Wave, Shelton, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 May 2013
- FDA classified
- 11 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 14 May 2013 | Recall initiated by company | |
| 11 Sep 2013 | Classified by FDA | +120 days |
| 18 Sep 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A component Superior endplate manufactured from a different polymer than specified
Product as listed by the FDA
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
Where it was distributed
Distributed in the states of FL and OR.
Questions about this recall
Why was it recalled?
A component Superior endplate manufactured from a different polymer than specified
Which lots are affected?
Lot Numbers: 272L08 and 272L09
Where was it sold?
Distributed in the states of FL and OR.
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.
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|---|---|---|---|---|---|
| Device | CLASS II | Access Kit recalled by Spine Wave | Spine Wave | Labeling Errors | Nationwide |
Other Spinal Implants recalls
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|---|---|---|---|---|---|
| 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 |