IdentiTi ALIF surgical graft bolts recalled due to intraoperative breakage
Alphatec Spine recalls IdentiTi ALIF graft bolts after reports of breakage during implantation. Approximately 12,777 devices are affected worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with documented implantation failures but no reported patient injuries. Meets rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The FDA is recalling IdentiTi ALIF Standalone Interbody System graft bolts manufactured by Alphatec Spine, Inc., classified as a Class II medical device recall. The products are surgical graft bolts in various sizes used in anterior lumbar interbody fusion (ALIF) procedures.
The recall was initiated following reports of graft bolt breakage during surgical implantation of these devices.
Approximately 12,777 devices have been distributed worldwide, including throughout multiple U.S. states and New Zealand. Affected lot numbers and product identification codes are documented in the FDA recall notice.
Healthcare providers should review the FDA recall notice and contact Alphatec Spine, Inc. for specific product identification and inventory management. Any adverse events related to these devices should be reported to the FDA.
The recalled product
- Product
- IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 132-10-90-250 / IdentiTi ALIF SA…
- Manufacturer
- Alphatec Spine, Inc.
- Affected units
- 12,777
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 08.5 x 25 mm UDI-DI code: 00190376299716 Lot Numbers: 8746709
- 8746724
- TO00212 132-10-85-300 / IdentiTi ALIF SA Graft Bolt
- 08.5 x 30 mm UDI-DI code: 00190376299730 Lot Numbers: 8746710
- 8746725
- TO00213 132-10-85-350 / IdentiTi ALIF SA Graft Bolt
- 08.5 x 35 mm UDI-DI code: 00190376299754 Lot Numbers: 8746711
- TO00218 132-10-90-250 / IdentiTi ALIF SA Graft Bolt
- 08.5 x 25 mm UDI-DI code: 00190376369976 Lot Numbers: TO00373
- TO00670
- TO00694
- TO00834
- TO01038
- TO01404
- TO01514
- TO01572
- TO01573
- TO01696
- TO01974
- TO01979
Distribution
Related recalls
Same manufacturer · Alphatec Spine, Inc.
See all →- HighSafeOp Patient Interface Neuromonitoring Device Recalled Due to Software Issue
FDA (Devices) · 2026-07-29
- ModerateSpinal navigation instruments recalled over incorrect array connection geometry
FDA (Devices) · 2026-02-18
- ModerateNavigation osteotomes recalled over incorrect array connection geometry
FDA (Devices) · 2026-02-18
- HighAlphatec Calibrate CCX Interbody Implants Recalled for Post-Operative Collapse
FDA (Devices) · 2025-02-05
- HighLIF AMP Adjustable Awl Recalled for Assembly Defect Preventing Depth Control
FDA (Devices) · 2023-09-06
Same hazard · implant breakage
See all →- HighCayenne Medical Recalls AperFix AM Femoral Implants Due to Breakage Risk
FDA (Devices) · 2018-07-18
- SevereOrthopedic Alliance Recalls Blue & Gold Spine System Implants
FDA (Devices) · 2013-05-01
- SevereSpinal Solutions Recalls APLIF Implants Due to Inadequate Testing
FDA (Devices) · 2013-05-01
Similar recalls
- HighFDA Recalls MectaLIF ANTERIOR Spinal Fusion Device Due to Screw Breakage Risk
FDA (Devices) · 2023-04-26
- HighAnterior Cervical Plate System Screw Mechanism May Fail Intraoperatively
FDA (Devices) · 2021-06-16
- HighInterventional Spine Recalls G3 Opticage Expandable Interbody Fusion Devices
FDA (Devices) · 2017-01-11
- ModerateMedicrea IMPIX ALIF Lumbar Fusion Devices Recalled for Packaging Defect
FDA (Devices) · 2023-08-30
- HighIntervertebral Fusion Device Recalled for Potential Packaging Defect
FDA (Devices) · 2023-08-30
- SevereIntegra External Fixation System Wire Fixation Bolts Recalled for Breakage
FDA (Devices) · 2016-08-17