Drug recall
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
FDA recall event 88422 · Class II · Howmedica Osteonics Corp.
Key facts
| Event ID | 88422 |
|---|---|
| Recall numbers | Z-2329-2021 |
| Recalling firm | Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert… |
| Initiation date | Jul 1, 2021 |
| Report date | Aug 25, 2021 |
| Termination date | May 17, 2023 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3003070421 |
At a glance
- 1–9 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: