Drug recall
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
FDA recall event 90738 · Class II · OrthoPediatrics Corp
Key facts
| Event ID | 90738 |
|---|---|
| Recall numbers | Z-1678-2022 |
| Recalling firm | OrthoPediatrics Corp |
| Product type | Devices |
| Products | Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could… |
| Initiation date | Jun 29, 2022 |
| Report date | Sep 14, 2022 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 3006460162 |
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: