Reef TA Inserter may fail to disengage properly during spinal surgery
SeaSpine Orthopedics is recalling 74 Reef TA Inserters due to potential difficulty disengaging the device during spinal fusion surgery, which may require surgical revision and alternate instrumentation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential for intraoperative complications requiring surgical revision; no adverse events reported. Risk-of-harm product where injury has not yet been reported.
Plain-English summary
SeaSpine Orthopedics Corporation is recalling 74 Reef TA Inserters (Part Number TA2-001003), part of the Reef Interbody System used in spinal fusion procedures. The inserter may not disengage properly from the implant during surgery or may allow improper implant positioning.
If the inserter fails to disengage or allows misalignment, the surgeon may need to perform an intraoperative revision or use alternate instrumentation, potentially prolonging the surgery. Additionally, some devices bear incorrect UDI-DI markings. No injuries have been reported.
The affected devices were distributed to medical facilities in Nevada, Texas, Idaho, Michigan, Ohio, South Dakota, Tennessee, Pennsylvania, Connecticut, Colorado, Florida, Washington, North Carolina, Oklahoma, Minnesota, and Hong Kong. Affected lot numbers include BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, and BT112779CR2.
Healthcare providers should immediately cease using affected devices and contact SeaSpine Orthopedics for replacement units or return instructions. Patients who may have received these implants should consult their healthcare provider if they have any concerns.
The recalled product
- Product
- Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Hazard
- improper-positioning
- device-malfunction
- surgical-complication
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- UDI-DI: 10889981290733
- 10889981437800. Lots: BT107376C
- BT112289C
- BT112779C
- BT107376CR1
- BT107376CR2
- BT107376CR1R2
- BT112289CR2
- BT112779CR2
Distribution
Distributed nationwide across the United States.
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