Drug recall
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L…
FDA recall event 85583 · Class II · Howmedica Osteonics Corp.
Key facts
| Event ID | 85583 |
|---|---|
| Recall numbers | Z-2084-2020, Z-2085-2020, Z-2086-2020, Z-2087-2020, Z-2088-2020, Z-2089-2020, Z-2090-2020, Z-2091-2020, Z-2092-2020, Z-2093-2020, Z-2094-2020, Z-2095-2020 and 4 more |
| Recalling firm | Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17), Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17), Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17), Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17), Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17) and 11 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. |
| Initiation date | Apr 16, 2020 |
| Report date | May 27, 2020 |
| Termination date | Nov 15, 2021 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3003070421 |
At a glance
- 10–99 Products in this recall
- 10–99 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: