FDA Device recall Z-0891-2017
Optimus Fixed Awl
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Optimus Fixed Awl by Amendia, citing complaints that the tip of the awl broke after impaction during surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0891-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-22 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Amendia |
| Distribution | FL, GA, IL, MO, TX |
Product
Optimus Fixed Awl
Reason
Complaints that the tip of the awl broke after impaction during surgery.
Identifiers
| code_info | Part Number 139005 - Lot Number 182-16146 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0891-2017%22
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