Alphatec Spine, Inc. recalled IdentiTi ALIF Standalone Interbody System graft bolts due to reports of intraoperative breakage, the FDA said on Jan. 26, 2024. Owners should contact the company for a replacement.
How to tell if you have it
- Brand: Alphatec
- Product: IdentiTi ALIF Standalone Interbody System / IdentiTi ALIF SA Graft Bolt / IdentiTi ALIF SA Cannulated Graft Bolt
- Part Numbers: 132-10-85-250, 132-10-85-300, 132-10-85-350, 132-10-90-250, 132-10-90-300, 132-10-90-350, 232-10-85-250, 232-10-85-300, 232-10-85-350, 232-11-90-250, 232-11-90-300, 232-11-90-350
- Sizes: 08.5 x 25 mm, 08.5 x 30 mm, 08.5 x 35 mm, 09 x 25 mm, 09 x 30 mm, 09 x 35 mm
- Units affected: 12,777 devices
The hazard
The recall is due to reports of intraoperative graft bolt implantation breakages.
Context
GovInfoNow's records show Alphatec Spine, Inc. has 6 other recalls on record since April 26, 2021. Other recent recalls include the Alphatec SafeOp Patient Interface Software Issue (May 13, 2026), the Alphatec LIF NAV Osteotome 10mm (Jan. 2, 2026), and the Alphatec Calibrate CCX Interbody System (Dec. 15, 2024). Other recent recalls of similar products include the Aju Pharm Genesis Dual Thread Screw-In Anchor (Dec. 17, 2025), the Genesis Push-In Suture Anchor (Dec. 17, 2025), and the Innovasis Anti-Torque Vector Pedicle Screw LS-749 (May 22, 2026).