Drug recall
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
FDA recall event 81723 · Class II · Conformis, Inc.
Key facts
| Event ID | 81723 |
|---|---|
| Recall numbers | Z-0731-2019 |
| Recalling firm | Conformis, Inc. |
| Product type | Devices |
| Products | iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm. |
| Initiation date | Oct 16, 2018 |
| Report date | Jan 23, 2019 |
| Termination date | Jun 29, 2020 |
| City | Billerica |
| State | MA |
| Country | United States |
| FEI number | 3009844603 |
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: