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 a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming. |
| Product | IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures. |
| Quantity | 156 units |
| Distribution | Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland. |
| Initiated | 2011-04-25 |
| Classified | 2012-11-26 |
| Terminated | 2013-03-21 |
| Recall number | Z-0438-2013 |
| 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-0438-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62918/
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