Drug recall
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on…
FDA recall event 69294 · Class II · Orthohelix Surgical Designs Inc
Key facts
| Event ID | 69294 |
|---|---|
| Recall numbers | Z-0062-2015 |
| Recalling firm | Orthohelix Surgical Designs Inc |
| Product type | Devices |
| Products | MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer |
| Initiation date | Sep 19, 2014 |
| Report date | Oct 15, 2014 |
| Termination date | Oct 31, 2016 |
| City | Medina |
| State | OH |
| Country | United States |
| FEI number | 3005039508 |
At a glance
- 1–9 Products in this recall
- None 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: