Atec Insignia Anterior Cervical Plate System Recall: Potential Screw Mechanism Failure
Alphatec Spine is recalling 7 units of the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock 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 a Class II medical device recall involving a potential structural defect in a surgical implant. While no reported illnesses or injuries have been documented, the hazard presents a risk of serious harm if the screw mechanism were to fail in a critical anatomical location.
Plain-English summary
Alphatec Spine, Inc. is recalling 7 units of the Atec Insignia Anterior Cervical Plate System, REF 136-0121 (1-Level, 21 mm, Code 8609306R).
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively or postoperatively, or to unlock postoperatively.
The affected 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.
The recalled product
- Product
- Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
- Manufacturer
- Alphatec Spine, Inc.
- Affected units
- 7
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)
- 8609306R
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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Same hazard · screw disassociation
See all →- HighAnterior cervical plate system screw mechanism may disassociate during or after surgery
FDA (Devices) · 2021-06-16
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- HighAlphatec Insignia Cervical Plate System: Screw Mechanism Disassociation Risk
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