Class 2 Device Recall IdentiTi ALIF Standalone Interbody System

• Date Initiated by Firm: January 26, 2024
• Date Posted: February 23, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1182-2024
• Recall Event ID: 93898
• 510(K)Number: K232097
• Product Classification: Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
• 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 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.
• Code Information: Part Number / Product Description / UDI-DI Code / Lot Number 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 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, 09 x 25 mm UDI-DI code: 00190376299792 Lot Numbers: 8746712 132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm UDI-DI code: 00190376299815 Lot Numbers: 6746713 132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm UDI-DI code: 00190376299839 Lot Numbers: 8746714 232-10-85-250 / 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, TO01982, TO02297, TO02393, TO03218, TO03465 232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376369990 Lot Numbers: TO00376, TO00671, TO00695, TO00710, TO00835, TO01039, TO01405, TO01515, TO01574, TO01575, TO01697, TO01975, TO01980, TO01983, TO02298, TO02394, TO03219, TO03466 232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376370019 Lot Numbers: TO00380, TO00672, TO00696, TO00836, TO01576, TO01577, TO02163, TO02395 232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm UDI-DI code: 00190376370293 Lot Numbers: TO00381, TO00673, TO00697, TO01277, TO01578, TO02396 232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm UDI-DI code: 00190376370316 Lot Numbers: TO00382, TO00674, TO00698, TO01040, TO01406, TO02164, TO02397, TO03220 232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm UDI-DI code: 00190376370330 Lot Numbers: TO00383, TO00699, TO01407, TO02398
• Recalling Firm/ Manufacturer: Alphatec Spine, Inc.; 1950 Camino Vida Roble; Carlsbad CA 92008-6505
• For Additional Information Contact: 760-431-9286
• Manufacturer Reason for Recall: Due to reports of intraoperative graft bolt implantation breakages.
• FDA Determined Cause: Device Design
• 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 QMSCompliance@atecspine.com or calling 1-800-922-1356.
• Quantity in Commerce: 12,777 devices
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OVD and Original Applicant = Alphatec Spine, Inc.