Optimus Fixed Awl
FDA Recall Z-0891-2017 · Posted 2016-12-22
Recalling FirmAmendia, Inc
Recall StatusTerminated
Product CodeOVD
Date Initiated2016-11-22
Date Terminated2017-02-28
Product Quantity9 devices
Reason for Recall
Complaints that the tip of the awl broke after impaction during surgery.
Firm 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.
Root Cause
Device Design
Distribution Pattern
US Distribution to the states of : FL, GA. IL, MO, TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.