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Recall Observatory FDA recall evidence

Device product

Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705

Z-1826-2021

April 26, 2021

Class II

Product summary

Firm
Alphatec Spine, Inc.
Event
Event 87887
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1826-2021

Official wording

Reason: There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

Code information: 8609334R

Distribution pattern: US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.