Skip to content
Recall Observatory FDA recall evidence

Device product

Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

Z-1156-2020

October 02, 2019

Class II

Product summary

Firm
Medicrea International
Event
Event 84770
Status
Terminated
Classification
Class II
Quantity
14 units
Official record key
device-enforcement:Z-1156-2020

Official wording

Reason: Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

Code information: Lot Numbers l9B0570; 19B0572

Distribution pattern: OH, VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter