SeaSpine Orthopedics recalled 74 Reef TA Inserter instruments used with the Reef Interbody System, distributed worldwide to hospitals and surgical centers. The inserter may cause difficulty disengaging the implant or improper positioning, prolonging surgery and possibly requiring intraoperative revision. Hospitals and surgeons should stop using the device and follow recall instructions from SeaSpn
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEASPINE ORTHOPEDICS CORPORATION or your healthcare provider for instructions. Notification method: Letter
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The Reef Interbody System is a spine fusion device used in surgical procedures. The Reef TA Inserter is an accompanying instrument designed to position the interbody device during surgery.
The inserter may cause difficulty disengaging the implant or improper positioning, which can lead to longer surgeries and possible intraoperative revisions. Incorrect UDI-DI markings may complicate device identification and recalls.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and surgeons must audit instrument kits to ensure only non-recalled devices are used. Delays or revisions can impact operating room schedules and patient recovery timelines.
UDI-DI markings are on device labels and packaging. Part numbers and model codes are on instrument handles and documentation provided with the Reef Interbody System.
Not specified by the manufacturer.
Keep recall letter, FDA notice, device labels, serials, and all correspondence with the manufacturer.
Part Number: TA2-001003 UDI-DI: 10889981290733 and 10889981437800 Other model codes: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2 Quantity recalled: 74 Sold worldwide; US distribution includes NV, TX, ID, MI, OH, SD, TN, PA, CT, CO, FL, WA, NC, OK, MN and Hong Kong Price: Unknown Sold since: Unknown Country of origin: Unknown
No injuries or incidents have been reported.
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