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Recall Observatory FDA recall evidence

Device product

16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1

Z-1037-2015

December 10, 2014

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 70184
Status
Terminated
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-1037-2015

Official wording

Reason: Customer complaint indicating the color bands on the MIA16-G1 were not correct.

Code information: Serial Numbers: H38309606702, H38309606704, H38309610105, H38309610104, H38309606701, H38309606703, H38309606705, H38309610101.

Distribution pattern: US Distribution to the states of: NC and CA., and Internationally to Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Customer complaint indicating the color bands on the MIA16-G1 were not correct.