Optimus Fixed Awl — Class II medical device recall Z-0891-2017
Terminated recall by Amendia, Inc, reported 2016-12-28, distributed in FL, GA, IL, MO, TX. Complaints that the tip of the awl broke after impaction during surgery.
| Recall number | Z-0891-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amendia, Inc, Marietta, GA, United States |
| Recall initiated | 2016-11-22 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-02-28 |
| Distributed | FL, GA, IL, MO, TX |
| Quantity | 9 devices |
| Lot numbers | 182-16146 |
| Model numbers | 139005 |
Product
Optimus Fixed Awl
Reason for recall
Complaints that the tip of the awl broke after impaction during surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0891-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.