Anterior Cervical Plate System Screw Mechanism May Disassociate or Unlock
Alphatec Spine recalls its Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during spinal surgery or unlock afterward. Healthcare providers should contact the manufacturer for guidance.
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 medical device recall involving a surgical implant with potential for device failure without reported injuries. Classified as a risk-of-harm product where injury has not yet been reported, per the rubric.
Plain-English summary
Alphatec Spine, Inc. is recalling the Atec Insignia Anterior Cervical Plate System (REF 136-0248, 2-Level, 48 mm) because the screw blocking mechanism may disassociate during surgery or unlock after surgery.
The recall affects 3 units with code numbers 8609319R and 8663404R. These units were distributed nationwide to healthcare facilities in: Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York.
Healthcare providers should contact Alphatec Spine for guidance on affected devices. Patients who have received this implant should consult with their surgeon regarding any concerns.
The recalled product
- Product
- Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
- Manufacturer
- Alphatec Spine, Inc.
- Category
- Medical Device — Spinal Implant
- Hazard
- device-failure
- screw-mechanism-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)
- 8609319R and 8663404R
Distribution
Distributed nationwide across the United States.
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