Z-0891-2017Class II

Optimus Fixed Awl

Name: Z-0891-2017 Optimus Fixed Awl
Creator: Amendia, Inc
Published: 2016-11-22
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2016-11-22 / Terminated / root cause: design

FDA source

Amendia, Inc began a recall of Optimus Fixed Awl on 2016-11-22. FDA classified it as Class II and gives the reason as "Complaints that the tip of the awl broke after impaction during surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0891-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2016-12-22
Terminated: 2017-02-28
Recalling firm: Spinal Elements, Inc
Product: Optimus Fixed Awl
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: Complaints that the tip of the awl broke after impaction during surgery.
Root cause tag: design
FDA root cause: Device Design
Action: Amendia Inc. sent an Urgent : Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. For further questions, please call (404) 610-7215.
Quantity in commerce: 9 devices
Distribution: US Distribution to the states of : FL, GA. IL, MO, TX
Product codes and lots: Part Number 139005 - Lot Number 182-16146

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0891-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0891-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

Product code OVD

K132596Class IIProposed OptimusCustom Spine, Inc. / cleared 2014-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)