Drug recall
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137…
FDA recall event 97006 · Class II · CORIN MEDICAL, LTD.
Key facts
| Event ID | 97006 |
|---|---|
| Recall numbers | Z-2069-2025 |
| Recalling firm | CORIN MEDICAL, LTD. |
| Product type | Devices |
| Products | Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches. |
| Initiation date | May 23, 2025 |
| Report date | Jul 9, 2025 |
| City | Cirencester |
| Country | United Kingdom |
| FEI number | 3002806725 |
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: