Drug recall
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is…
FDA recall event 89972 · Class II · Synthes (USA) Products LLC
Key facts
| Event ID | 89972 |
|---|---|
| Recall numbers | Z-1072-2022 |
| Recalling firm | Synthes (USA) Products LLC |
| Product type | Devices |
| Products | Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis. |
| Initiation date | Apr 7, 2022 |
| Report date | May 18, 2022 |
| City | West Chester |
| State | PA |
| Country | United States |
| FEI number | 3008812560 |
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: