Safety Alert: Class II: 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.
healthClass IIRecalled on Sep 17, 2025
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
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Sold At: SEASPINE ORTHOPEDICS CORPORATION(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.)
Recall #: FDA-DEVICE-Z-2554-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2
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Summary
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.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact SEASPINE ORTHOPEDICS CORPORATION for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.