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 | Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected). |
| Product | Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device. |
| Quantity | 93 units |
| Distribution | Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA. |
| Initiated | 2012-03-22 |
| Classified | 2013-01-30 |
| Terminated | 2013-06-13 |
| Recall number | Z-0752-2013 |
| 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-0752-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63805/
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