Drug recall
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation…
FDA recall event 90557 · Class II · DePuy Orthopaedics, Inc.
Key facts
| Event ID | 90557 |
|---|---|
| Recall numbers | Z-1419-2022 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Product type | Devices |
| Products | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide… |
| Initiation date | Jun 29, 2022 |
| Report date | Jul 27, 2022 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1818910 |
At a glance
- 1–9 Products in this recall
- None 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: