Drug recall
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage…
FDA recall event 71461 · Class II · Omnilife Science Inc.
Key facts
| Event ID | 71461 |
|---|---|
| Recall numbers | Z-2445-2015 |
| Recalling firm | Omnilife Science Inc. |
| Product type | Devices |
| Products | APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device may have improper screw hole placement due to inaccurate location of the index line. |
| Initiation date | Jun 4, 2015 |
| Report date | Sep 2, 2015 |
| Termination date | Sep 28, 2015 |
| City | East Taunton |
| State | MA |
| Country | United States |
| FEI number | 3008342029 |
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: