FDA Device recall Z-0344-2013
IO Fix IntraOsseous Fixation System
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of IO Fix IntraOsseous Fixation System by Extremity Medical, citing product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0344-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-04-13 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Extremity Medical |
| Distribution | US |
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
Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
Identifiers
| code_info | Product coding is listed as Catalog Number: Lot Number and are as follows: 118-30014:107509; 118-30016:107510; 118-300…Product coding is listed as Catalog Number: Lot Number and are as follows: 118-30014:107509; 118-30016:107510; 118-30018:107511; 118-30020:107512; 118-30020:107513; 118-30022:107514; 118-30024:107515; 118-30026:107516; 118-40020:107457; 118-40025:107458; 118-40030;107529; 118-40030;107459; 118-40035:107460; 118-40040:107461; 118-40045:107462; 118-40050:107463; 118-40320:107613; 118-40325:107614; 118-40330:107615; 118-40330:107616; 118-40335:107617; 118-40340:107618; 118-40345:107619; 118-40350:107620. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0344-2013%22
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