Recall Z-0779-2014— The Anspach Effort, Inc.

Name: FDA recall Z-0779-2014
Creator: U.S. Food and Drug Administration
Published: 2013-05-06

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2013-05-06, terminated 2016-04-18. It names 2 FDA 510(k) clearances: K011444, K965080. 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.. Reason: Product did not reach expected sterility assurance level.

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-06
Terminated: 2016-04-18
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K011444 — ANSPACH EMAX DRILL SYSTEMThe Anspach Effort, Inc.·cleared 2001-08-08
K965080 — ANSPACH MICROMAX SYSTEMThe Anspach Effort, Inc.·cleared 1997-01-10

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

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

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