Amendia, Inc: Medical Device Recall in 2016 - (Recall #: Z-0891-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Optimus Fixed Awl

Product Classification:

Class II

Date Initiated: November 22, 2016

Date Posted: December 28, 2016

Recall Number: Z-0891-2017

Event ID: 75856

Reason for Recall:

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

Status: Terminated

Product Quantity: 9 devices

Code Information:

Part Number 139005 - Lot Number 182-16146

Distribution Pattern:

US Distribution to the states of : FL, GA. IL, MO, TX

Voluntary or Mandated:

Voluntary: Firm initiated