Alphatec Insignia Cervical Plate System: Screw Mechanism Disassociation Risk
Alphatec recalls the Insignia Anterior Cervical Plate System due to risk that the screw blocking mechanism may disassociate during or after surgery.
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: This is an FDA Class II recall of a surgical implant with a potential mechanism failure where the screw blocking system may disassociate during or after surgery. No illnesses or injuries have been reported, placing it in the High category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alphatec Spine, Inc. is recalling the Insignia Anterior Cervical Plate System, a surgical implant used in cervical spine procedures. The specific recalled product reference is REF 136-0468 (code 8609331R), and 2 units have been distributed.
The FDA has determined there is a potential for the screw blocking mechanism to disassociate during surgery (intraoperatively) or unlock after surgery (postoperatively). This defect could compromise the stability of the implant.
The recalled units were distributed to medical facilities in Florida, California, Illinois, Oklahoma, Texas, Connecticut, Indiana, North Carolina, Washington, Hawaii, Idaho, Massachusetts, South Carolina, New Mexico, and New York. Healthcare providers and patients who have received this implant should contact Alphatec Spine or their healthcare provider for additional information and guidance.
The recalled product
- Product
- Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
- Manufacturer
- Alphatec Spine, Inc.
- Category
- Medical Device — Spinal Implant
- Affected units
- 2
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)
- 8609331R
Distribution
Part of a larger recall action
This product is one of 29 recalled by Alphatec Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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