Cervical Spine Plate System Screw Mechanism May Disassociate or Unlock
Alphatec Spine recalls its Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism, which may disassociate or unlock during or after spinal surgery.
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 recall involving a potential mechanical failure of a critical spinal implant with no reported illnesses or injuries. The hazard is theoretical, placing this at the maximum severity for recalls with no actual adverse events, consistent with risk-of-harm products.
Plain-English summary
Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0120, 1-Level, 20 mm) used in anterior cervical spine fusion surgery. The system's screw blocking mechanism has the potential to disassociate or unlock during or after surgery, which could compromise the stability of the surgical repair.
Approximately 10 units were distributed to medical facilities in 15 states: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.
No illnesses or injuries have been reported in connection with this defect. Patients and healthcare providers should be aware of this potential mechanical failure and contact Alphatec Spine with any questions or concerns regarding this recall.
The recalled product
- Product
- Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
- Manufacturer
- Alphatec Spine, Inc.
- Hazard
- implant-failure
- mechanical-failure
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 (1)
- 8609305R
Distribution
Distributed nationwide across the United States.
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