Drug recall
SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS…
FDA recall event 79218 · Class II · ORTHO SOLUTIONS, LTD.
Key facts
| Event ID | 79218 |
|---|---|
| Recall numbers | Z-0967-2018 |
| Recalling firm | ORTHO SOLUTIONS, LTD. |
| Product type | Devices |
| Products | SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot… |
| Initiation date | Oct 10, 2017 |
| Report date | Mar 21, 2018 |
| Termination date | Aug 31, 2018 |
| City | Maldon |
| Country | United Kingdom |
| FEI number | 3008951116 |
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: