Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
FDA device recall Z-2554-2025 · posted 2025-09-11 · Open, Classified
Recall details
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Reason for recall
- 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.
- Action taken
- 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 within your organization and forwarded to any organization where potentially affected devices have been transferred. Should you have any questions regarding this matter, please contact the firm at: dominiquepetach@orthofix.com
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- MAX
- Quantity affected
- 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.
- Date initiated
- 2025-08-06
- Date posted
- 2025-09-11
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SeaSpine Beachside System (K192132) | SeaSpine Orthopedics Corporation | 2019-12-03 |