Drug recall
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
FDA recall event 79791 · Class II · Kelyniam Global, Inc.
Key facts
| Event ID | 79791 |
|---|---|
| Recall numbers | Z-1870-2018, Z-1871-2018, Z-1872-2018, Z-1873-2018 |
| Recalling firm | Kelyniam Global, Inc. |
| Product type | Devices |
| Products | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small), Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002, Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003, Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the… |
| Initiation date | Jun 10, 2017 |
| Report date | May 23, 2018 |
| Termination date | Sep 14, 2020 |
| City | Collinsville |
| State | CT |
| Country | United States |
| FEI number | 3009424796 |
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: