Class II — Extremity Medical LLC
| Recalling firm | Extremity Medical, LLC |
|---|---|
| Registered facility | Extremity Medical, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. |
| 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. |
| Quantity | 120 Units |
| Distribution | Worldwide Distribution-USA (nationwide) including the states FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE, and the country of Switzerland. |
| Initiated | 2011-04-13 |
| Classified | 2012-11-17 |
| Terminated | 2013-03-21 |
| Recall number | Z-0344-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Extremity Medical LLC (Z-0344-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62916/
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