Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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 Graft Bolt, 09 x 25 mm 132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm 132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm 232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm 232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm 232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures.

FDA Recall Z-1182-2024 · Posted 2024-02-23

Recalling FirmAlphatec Spine, Inc.
Recall StatusOpen, Classified
Product CodeOVD
Date Initiated2024-01-26
Product Quantity12,777 devices

Reason for Recall

Due to reports of intraoperative graft bolt implantation breakages.

Firm Action

On 01/26/2024, the firm emailed an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" Letter to customer informing them that, The Surgical Technique Guide, LIT-85141, and Instructions for Use, INS-130, were revised to require hole preparation prior to insertion of an IdentiTi SA Graft Bolt, as well as to add a new caution statement, to confirm with fluoroscopy that the graft bolt insertion angle is as close as possible to a 40-degree trajectory. The revised labeling mitigates potential fracturing of the Graft Bolt intra-operatively or post-operatively. Customer are instructed to: Please share this notice with all of those who need to be aware within your organization or any organization where the affected product has been transferred. - Inform doctors and surgical staff of the labeling (surgical technique and instructions for use) - Please fill out the last page of this letter to confirm that you have read this notification and will complete the necessary actions as described in this notification. - If you have any questions/concerns or require assistance with the correction, please contact by e-mailing [email protected] or calling 1-800-922-1356.

Root Cause

Device Design

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KS, KY, MD, MI, MN, MS, NC, NH, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, WA and WI. The country of New Zealand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. · 2023-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑