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Recall Observatory FDA recall evidence

Device product

The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.

Z-0225-2015

October 21, 2014

Class II

Product summary

Firm
Medacta Usa
Event
Event 69693
Status
Terminated
Classification
Class II
Quantity
32 oblique handles
Official record key
device-enforcement:Z-0225-2015

Official wording

Reason: The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.

Code information: Model Number: 03.22.10.0262; Lot Number: 1314256

Distribution pattern: Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.

Field note

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