Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
Reported: June 16, 2021 Initiated: April 26, 2021 #Z-1823-2021
Product Description
Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
Reason for Recall
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Details
- Recalling Firm
- Alphatec Spine, Inc.
- Units Affected
- 1 units
- Distribution
- US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.
- Location
- Carlsbad, CA
Frequently Asked Questions
What product was recalled? ▼
Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637. Recalled by Alphatec Spine, Inc.. Units affected: 1 units.
Why was this product recalled? ▼
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 16, 2021. Severity: Moderate. Recall number: Z-1823-2021.
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