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Recall Observatory FDA recall evidence

Device product

Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.

Z-0779-2014

May 06, 2013

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 67179
Status
Terminated
Classification
Class II
Quantity
183
Official record key
device-enforcement:Z-0779-2014

Official wording

Reason: Product did not reach expected sterility assurance level

Code information: ALL LOTS

Distribution pattern: Nationwide Distribution: FL, IL, CA. IN, MI, CA, NJ, TX, NE, NC, OR, PA, TN, DC, UT, CO, MO, KY, MD, WV, NY, and MN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product did not reach expected sterility assurance level