IO FiX X-Post Reamer — Class II medical device recall Z-0438-2013
Terminated recall by Extremity Medical LLC, reported 2012-12-05, distributed in AL, AZ, CA, FL, GA, IA, IL, IN…. Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed p
| Recall number | Z-0438-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Extremity Medical LLC, Parsippany, NJ, United States |
| Recall initiated | 2011-04-25 |
| Classified | 2012-11-26 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2013-03-21 |
| Distributed | AL, AZ, CA, FL, GA, IA, IL, IN, MA, MD, MI, MT, NC, NE, NJ, NY, OH, OK, TN, TX, VA, WI |
| Countries outside the US | CH |
| Quantity | 156 units |
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.
Reason for recall
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
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-0438-2013. 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.