Drug recall
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)…
FDA recall event 85108 · Class II · Conformis, Inc.
Key facts
| Event ID | 85108 |
|---|---|
| Recall numbers | Z-1627-2020, Z-1628-2020 |
| Recalling firm | Conformis, Inc. |
| Product type | Devices |
| Products | iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee…, iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. |
| Initiation date | Feb 3, 2020 |
| Report date | Apr 8, 2020 |
| Termination date | Dec 2, 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: