Drug recall
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part #…
FDA recall event 88223 · Class II · Encore Medical, LP
Key facts
| Event ID | 88223 |
|---|---|
| Recall numbers | Z-2331-2021 |
| Recalling firm | Encore Medical, LP |
| Product type | Devices |
| Products | AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery. |
| Initiation date | Jun 28, 2021 |
| Report date | Sep 1, 2021 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 1000116912 |
At a glance
- 1–9 Products in this recall
- 10–99 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: