CLASS II Device recall · Reported 14 Aug 2013 · FDA Enforcement Report
T-Handle, Strike Plate, Push Connection recalled by SpineFrontier
SpineFrontier is recalling T-Handle, Strike Plate, Push Connection, distributed in Massachusetts, Nevada, Texas. The recall was initiated on 29 Aug 2012 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-1932-2013
- FDA event ID
- 64993
- Recalling firm
- SpineFrontier, Beverly, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Aug 2012
- FDA classified
- 8 Aug 2013
- Reported
- 14 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 29 Aug 2012 | Recall initiated by company | |
| 8 Aug 2013 | Classified by FDA | +344 days |
| 14 Aug 2013 | 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
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Product as listed by the FDA
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
Where it was distributed
US Distribution including the states of MA, NV and TX.
Questions about this recall
Why was it recalled?
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Which lots are affected?
Lot Numbers: 1335201A, 1446101A
Where was it sold?
US Distribution including the states of MA, NV and TX.
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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|---|---|---|---|---|---|
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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 |