Recall Z-1037-2015— The Anspach Effort, Inc.

Name: FDA recall Z-1037-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-10

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2014-12-10, terminated 2016-05-09. It names one FDA 510(k) clearance: K133604. Product: 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1. Reason: Customer complaint indicating the color bands on the MIA16-G1 were not correct..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-12-10
Terminated: 2016-05-09
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTSThe Anspach Effort, Inc.·cleared 2014-01-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.