Drug recall
01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper…
FDA recall event 77069 · Class II · Amendia, Inc
Key facts
| Event ID | 77069 |
|---|---|
| Recall numbers | Z-1885-2017 |
| Recalling firm | Amendia, Inc |
| Product type | Devices |
| Products | 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol. |
| Initiation date | Apr 6, 2017 |
| Report date | May 3, 2017 |
| Termination date | May 30, 2017 |
| City | Marietta |
| State | GA |
| Country | United States |
| FEI number | 3007970248 |
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: