Drug recall
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36…
FDA recall event 68043 · Class II · Smith & Nephew Inc
Key facts
| Event ID | 68043 |
|---|---|
| Recall numbers | Z-1636-2014, Z-1637-2014 |
| Recalling firm | Smith & Nephew Inc |
| Product type | Devices |
| Products | TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF…, TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. |
| Initiation date | Apr 4, 2014 |
| Report date | May 28, 2014 |
| Termination date | Jul 1, 2017 |
| 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: