Drug recall
AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable…
FDA recall event 77221 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 77221 |
|---|---|
| Recall numbers | Z-2215-2017 |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | nail not properly engaging with the targeting jig due to certain undersized specification |
| Initiation date | Apr 17, 2017 |
| Report date | Jun 7, 2017 |
| Termination date | Aug 6, 2019 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1825034 |
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: