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Recall Observatory FDA recall evidence

Device product

Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.

Z-0776-2014

September 24, 2013

Class II

Product summary

Firm
SpineFrontier, Inc.
Event
Event 66298
Status
Terminated
Classification
Class II
Quantity
23 devices in total
Official record key
device-enforcement:Z-0776-2014

Official wording

Reason: Handles and heads may not be compatible.

Code information: CT128047, CT128048

Distribution pattern: US Distribution: VA only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Handles and heads may not be compatible.