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Recall Observatory FDA recall evidence

Device product

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90113, UDI # 10888857108264, Size 24x10mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

Z-2011-2020

April 13, 2020

Class II

Product summary

Firm
K2M, Inc
Event
Event 85491
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2011-2020

Official wording

Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.

Code information: Lot # FKWY

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, Missouri and the country of Europe.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.

Field note

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