16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, in...

FDA Recall #Z-1037-2015 — Class II — December 10, 2014

Recall #Z-1037-2015 Date: December 10, 2014 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

The Anspach Effort, Inc. — Palm Beach Gardens, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

8

Distribution

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

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated