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
Product summary
- 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
Product did not reach expected sterility assurance level