Drug recall
LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for…
FDA recall event 84059 · Class II · Smith & Nephew, Inc.
Key facts
| Event ID | 84059 |
|---|---|
| Recall numbers | Z-0351-2020 |
| Recalling firm | Smith & Nephew, Inc. |
| Product type | Devices |
| Products | LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully… |
| Initiation date | Oct 7, 2019 |
| Report date | Nov 20, 2019 |
| Termination date | Mar 8, 2023 |
| City | Memphis |
| State | TN |
| Country | United States |
| FEI number | 1020279 |
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: