CLASS II Device recall · Reported 12 Jun 2013 · FDA Enforcement Report
Straight Impactor - Dorado IBC recalled by SpineFrontier
SpineFrontier is recalling Straight Impactor - Dorado IBC, distributed nationwide in the US. The recall was initiated on 10 May 2008 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-1482-2013
- FDA event ID
- 64991
- Recalling firm
- SpineFrontier, Beverly, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 May 2008
- FDA classified
- 5 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 10 May 2008 | Recall initiated by company | |
| 5 Jun 2013 | Classified by FDA | +1852 days |
| 12 Jun 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
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Product as listed by the FDA
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
Where it was distributed
Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
Questions about this recall
Is Straight Impactor - Dorado IBC recalled?
Yes. SpineFrontier recalled Straight Impactor - Dorado IBC on 10 May 2008. The recall is Class II and its status is Terminated. Recall number Z-1482-2013.
Why was it recalled?
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Which lots are affected?
Lot number: 20856
Where was it sold?
Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
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.
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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 |
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