Drug recall
Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to…
FDA recall event 71492 · Class II · Synthes (USA) Products LLC
Key facts
| Event ID | 71492 |
|---|---|
| Recall numbers | Z-2091-2015 |
| Recalling firm | Synthes (USA) Products LLC |
| Product type | Devices |
| Products | Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part… |
| Initiation date | Jun 10, 2015 |
| Report date | Jul 22, 2015 |
| Termination date | Aug 18, 2016 |
| City | West Chester |
| State | PA |
| Country | United States |
| FEI number | 3008812560 |
At a glance
- 1–9 Products in this recall
- 1–9 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: