Drug recall
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post…
FDA recall event 62918 · Class II · Extremity Medical LLC
Key facts
| Event ID | 62918 |
|---|---|
| Recall numbers | Z-0438-2013 |
| Recalling firm | Extremity Medical LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming. |
| Initiation date | Apr 25, 2011 |
| Report date | Dec 5, 2012 |
| Termination date | Mar 21, 2013 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3007289093 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: