Drug recall
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total…
FDA recall event 95258 · Class II · Tornier, Inc
Key facts
| Event ID | 95258 |
|---|---|
| Recall numbers | Z-3155-2024 |
| Recalling firm | Tornier, Inc |
| Product type | Devices |
| Products | stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). |
| Initiation date | Aug 29, 2024 |
| Report date | Sep 25, 2024 |
| City | Bloomington |
| State | MN |
| Country | United States |
| FEI number | 3000718467 |
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: