Extremity Medical — Class II medical device recall Z-0752-2013
Terminated recall by Extremity Medical LLC, reported 2013-02-06, distributed nationwide. Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010)
| Recall number | Z-0752-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Extremity Medical LLC, Parsippany, NJ, United States |
| Recall initiated | 2012-03-22 |
| Classified | 2013-01-30 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2013-06-13 |
| Distributed | Nationwide (US) |
| Quantity | 93 units |
| Lot numbers | AP3V12, AP4E01, AP4N04, AP5E25, AP6A44, AP6E42, AP6L14, AP6M17, AP6T08 |
| Model numbers | 101-00010 |
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.
Reason for recall
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).
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-0752-2013. 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.