Drug recall
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip…
FDA recall event 77002 · Class II · Exactech, Inc.
Key facts
| Event ID | 77002 |
|---|---|
| Recall numbers | Z-2644-2017 |
| Recalling firm | Exactech, Inc. |
| Product type | Devices |
| Products | Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution… |
| Initiation date | May 22, 2017 |
| Report date | Jul 5, 2017 |
| Termination date | Jul 26, 2019 |
| City | Gainesville |
| State | FL |
| Country | United States |
| FEI number | 1038671 |
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: