PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 22, 2014 Initiated: May 6, 2013 #Z-0779-2014

Product Description

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.

Reason for Recall

Product did not reach expected sterility assurance level

Details

Recalling Firm
The Anspach Effort, Inc.
Units Affected
183
Distribution
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.
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled?
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.. Recalled by The Anspach Effort, Inc.. Units affected: 183.
Why was this product recalled?
Product did not reach expected sterility assurance level
Which agency issued this recall?
This recall was issued by the FDA Devices on January 22, 2014. Severity: Moderate. Recall number: Z-0779-2014.