Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Summary
The FDA issued a Class II for Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System by SEASPINE ORTHOPEDICS CORPORATION. Reason: Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant.
Details
Source
Device Recall
External ID
Z-2554-2025
Action Date
2025-09-17
Status
Ongoing
Category
device
Product Description
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Lot/Code Info: UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2
Quantity Affected: 74
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-06
Company
Carlsbad, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SEASPINE ORTHOPEDICS CORPORATION has 30 FDA actions in our database, including 9 recalls and 21 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SEASPINE ORTHOPEDICS CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SEASPINE ORTHOPEDICS CORPORATION have FDA actions?
SEASPINE ORTHOPEDICS CORPORATION has 30 FDA actions in our database, including 9 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2554-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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