Spinal inserters recalled over difficulty disengaging implants and incorrect UDI marking
Reef TA Inserters, part number TA2-001003, are recalled because they may contribute to difficulty disengaging the implant or improper implant positioning, and may carry incorrect UDI-DI marking. 74 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; improper implant positioning and intraoperative revision are potential harms and no injuries are reported.
Plain-English summary
The Reef TA Inserter, part number TA2-001003, part of the Reef Interbody System, is being recalled under UDI-DI 10889981290733 and 10889981437800. Affected lots include BT107376C, BT112289C, BT112779C, BT107376CR1 and BT107376CR2, with the full list in the recall notice. The recall covers 74 units distributed across more than 14 states and internationally.
The inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning. The manufacturer states this may lead to prolonged surgery or intraoperative revision and may require the use of alternate instrumentation. The devices may also have incorrect UDI-DI marking. The FDA classified the action as Class II.
Hospitals and surgical centres holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Affected units
- 74
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
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