FDA Medical devices recall ·
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody… recall
- Recall number
- Z-2554-2025
- Date
- (initiated August 6, 2025)
- Company / brand
- Seaspine Orthopedics Corporation
5770 Armada Dr, Carlsbad, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 74
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2
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.
States: Colorado Connecticut Florida Idaho Michigan Minnesota North Carolina Nevada Ohio Oklahoma Pennsylvania South Dakota Tennessee Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2554-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.