Recall Z-0891-2017— Amendia, Inc

Name: FDA recall Z-0891-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-22

Class II · Terminated

Class II FDA medical device recall by Amendia, Inc, initiated 2016-11-22, terminated 2017-02-28. It names one FDA 510(k) clearance: K132596. Product: Optimus Fixed Awl. Reason: Complaints that the tip of the awl broke after impaction during surgery..

Recalling firm: Amendia, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Terminated: 2017-02-28
Firm location: Marietta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K132596 — PROPOSED OPTIMUSCustom Spine, Inc.·cleared 2014-04-11

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

Optimus Fixed Awl

Reason for recall

Complaints that the tip of the awl broke after impaction during surgery.

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