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.
What this means for you
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 G
- Manufacturer
- Alphatec Spine, Inc.
- Hazard
- implant-breakage
- intraoperative-failure
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
Distributed nationwide across the United States.
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