Drug recall
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA recall event 85321 · Class II · ArthroCare Corporation
Key facts
| Event ID | 85321 |
|---|---|
| Recall numbers | Z-3000-2020 |
| Recalling firm | ArthroCare Corporation |
| Product type | Devices |
| Products | Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use. |
| Initiation date | Feb 21, 2019 |
| Report date | Sep 30, 2020 |
| Termination date | Aug 17, 2022 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 3006524618 |
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: