Recall Z-1182-2024 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Alphatec Spine, Inc.
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
| Date | Feb 23, 2024 (initiated Jan 26, 2024) |
| Status | Open, Classified |
| Reason | Due to reports of intraoperative graft bolt implantation breakages. |
| Root 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 n |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232097 | IdentiTi ALIF Interbody Systems Alphatec Spine, Inc., Sep 25, 2023 |