Alphatec Spine, Inc. is recalling approximately 12,777 IdentiTi ALIF Standalone Interbody System graft bolts because the bolts may break while being implanted during spinal surgery. The recall affects several models and sizes, including standard and cannulated graft bolts used in anterior lumbar interbody fusion procedures. Because these components are used during surgery, any breakage could lead to surgical delays, potential injury to the patient, or the need for additional medical intervention. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding these medical devices.
The graft bolts can break during the implantation process while the surgeon is securing the spinal device. This defect could cause metal fragments to remain in the patient or lead to an unstable spinal implant, potentially requiring revision surgery.
Medical Device Consultation and Return
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 ยท Raw API Response
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