IO Fix IntraOsseous Fixation System — Class II medical device recall Z-0344-2013
Terminated recall by Extremity Medical LLC, reported 2012-11-28, distributed nationwide. Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
| Recall number | Z-0344-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Extremity Medical LLC, Parsippany, NJ, United States |
| Recall initiated | 2011-04-13 |
| Classified | 2012-11-17 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-03-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH |
| Quantity | 120 units |
Product
IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.
Reason for recall
Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
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-0344-2013. 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.