Integrity Implants Inc. is recalling nine units of its Repeater Bone Tamp (Model ASY-00132) due to a mechanical incompatibility with specific bone funnels. This device is a cylindrical shaft used by surgeons during spinal fusion procedures to push bone graft material through a funnel and into a spinal implant. No injuries or incidents have been reported in connection with this issue.
The incompatibility between the bone tamp (Revision A) and bone funnels (Revision C) may prevent the device from functioning correctly during surgery. This could lead to procedural delays or difficulties in delivering bone graft material to the intended surgical site.
Revision A of bone tamp is incompatible with Revision C of bone funnels. Complete UDI: (01)00810004721906(10)03200045.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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