Recall Z-2554-2025 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
SEASPINE ORTHOPEDICS CORPORATION
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
| Date | Sep 11, 2025 (initiated Aug 6, 2025) |
| Status | Open, Classified |
| Reason | Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking. |
| Root cause | Device Design |
| Action | On 8/6/2025, recall notices were emailed to customers and distributors who were informed of the following: A laser marking error was identified in which the TA2-001003 inserters were incorrectly marked with the UDI-DI for model TA2-001002 (10889981290733). Updated Revision E Inserters have been shipped to you via overnight delivery. Kindly replace all existing Revision C/R1/R2 Inserters with the enclosed Revision E units. Return the Revision C Inserters to the recalling firm using provided RGA and prepaid shipping label. This recall notice should be shared with anyone who needs to be aware |
| Quantity | 74 |
| Distribution | Worldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH, SD, TN, PA, CT, CO, FL, WA, NC, OK, MN and the country of Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192132 | SeaSpine Beachside System SeaSpine Orthopedics Corporation, Dec 3, 2019 |