Drug recall
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual…
FDA recall event 89983 · Class II · restor3d Inc.
Key facts
| Event ID | 89983 |
|---|---|
| Recall numbers | Z-1026-2022, Z-1027-2022, Z-1028-2022 |
| Recalling firm | restor3d Inc. |
| Product type | Devices |
| Products | Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument, Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument, Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots., Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. |
| Initiation date | Mar 30, 2022 |
| Report date | May 11, 2022 |
| Termination date | Aug 28, 2023 |
| City | Durham |
| State | NC |
| Country | United States |
| FEI number | 3014833750 |
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: