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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Alphatec Spine, Inc.: IdentiTi ALIF Graft Bolts Recalled for Breakage Risk During Surgery

Agency Publication Date: February 23, 2024
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Summary

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.

Risk

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.

What You Should Do

  1. Identify if your device is affected by checking the model and lot numbers against the list provided by your surgical facility or healthcare provider. Affected products include IdentiTi ALIF SA Graft Bolts and Cannulated Graft Bolts in sizes 08.5 x 25 mm, 08.5 x 30 mm, 08.5 x 35 mm, 09 x 25 mm, 09 x 30 mm, and 09 x 35 mm.
  2. Check for specific lot numbers such as 8746709, 8746724, TO00212, 8746710, TO00213, 8746711, TO00218, 8746712, 6746713, 8746714, and various TO-series codes (e.g., TO00373, TO01404, TO03218) located on the product labeling or surgical records.
  3. If you are a patient who has recently undergone a spinal fusion procedure using the IdentiTi ALIF system, contact your surgeon or healthcare provider to discuss the status of your implant and whether any further monitoring is required.
  4. Hospitals and surgical centers should immediately stop using the affected lot numbers and contact Alphatec Spine, Inc. at 1-950 Camino Vida Roble, Carlsbad, California, 92008 for instructions on returning the product.
  5. For more information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit the official website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Medical Device Consultation and Return

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm
Model / REF:
132-10-85-250
232-10-85-250
UPC Codes:
00190376299716
00190376369976
Lot Numbers:
8746709
8746724
TO00212
TO00373
TO00670
TO00694
TO00834
TO01038
TO01404
TO01514
TO01572
TO01573
TO01696
TO01974
TO01979
TO01982
TO02297
TO02393
TO03218
TO03465
Product: IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm
Model / REF:
132-10-85-300
232-10-85-300
UPC Codes:
00190376299730
00190376369990
Lot Numbers:
8746710
8746725
TO00213
TO00376
TO00671
TO00695
TO00710
TO00835
TO01039
TO01405
TO01515
TO01574
TO01575
TO01697
TO01975
TO01980
TO01983
TO02298
TO02394
TO03219
TO03466
Product: IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm
Model / REF:
132-10-85-350
232-10-85-350
UPC Codes:
00190376299754
00190376370019
Lot Numbers:
8746711
TO00218
TO00380
TO00672
TO00696
TO00836
TO01576
TO01577
TO02163
TO02395
Product: IdentiTi ALIF SA Graft Bolt, 09 x 25 mm
Model / REF:
132-10-90-250
UPC Codes:
00190376299792
Lot Numbers:
8746712
Product: IdentiTi ALIF SA Graft Bolt, 09 x 30 mm
Model / REF:
132-10-90-300
UPC Codes:
00190376299815
Lot Numbers:
6746713
Product: IdentiTi ALIF SA Graft Bolt, 09 x 35 mm
Model / REF:
132-10-90-350
UPC Codes:
00190376299839
Lot Numbers:
8746714
Product: IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm
Model / REF:
232-11-90-250
UPC Codes:
00190376370293
Lot Numbers:
TO00381
TO00673
TO00697
TO01277
TO01578
TO02396
Product: IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm
Model / REF:
232-11-90-300
UPC Codes:
00190376370316
Lot Numbers:
TO00382
TO00674
TO00698
TO01040
TO01406
TO02164
TO02397
TO03220
Product: IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm
Model / REF:
232-11-90-350
UPC Codes:
00190376370330
Lot Numbers:
TO00383
TO00699
TO01407
TO02398

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93898
Status: Active
Manufacturer: Alphatec Spine, Inc.
Sold By: Hospitals; Surgical Centers; Medical Device Distributors
Manufactured In: United States
Units Affected: 12,777 devices
Distributed To: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin

Were You Affected by This Recall?

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.

Find an Attorney

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.