Drug recall
Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
FDA recall event 78763 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 78763 |
|---|---|
| Recall numbers | Z-0420-2018, Z-0421-2018, Z-0422-2018, Z-0423-2018, Z-0424-2018, Z-0425-2018, Z-0426-2018, Z-0427-2018, Z-0428-2018, Z-0429-2018, Z-0430-2018, Z-0431-2018 and 53 more |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM, Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM, Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM, Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM, Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM and 60 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed… |
| Initiation date | Aug 7, 2017 |
| Report date | Feb 7, 2018 |
| Termination date | Mar 29, 2019 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1825034 |
At a glance
- 10–99 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: