ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012 — Class II medical device recall Z-1819-2015
Terminated recall by Orthofix, Inc, reported 2015-07-01, distributed nationwide. There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threade
| Recall number | Z-1819-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix, Inc, Lewisville, TX, United States |
| Recall initiated | 2015-05-11 |
| Classified | 2015-06-22 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2016-02-17 |
| Distributed | Nationwide (US) |
| Quantity | 36 units |
Product
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
Reason for recall
There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.
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-1819-2015. 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.