Drug recall
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable…
FDA recall event 81096 · Class II · Howmedica Osteonics Corp.
Key facts
| Event ID | 81096 |
|---|---|
| Recall numbers | Z-0207-2019 |
| Recalling firm | Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm received complaints related to the locking mechanism on the steerable inserter not functioning as intended. The firm confirmed that the issue is related to lack of lubrication of the… |
| Initiation date | Sep 12, 2018 |
| Report date | Oct 31, 2018 |
| Termination date | Jul 16, 2020 |
| City | Allendale |
| State | NJ |
| Country | United States |
| FEI number | 3004024955 |
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: