Univation X System knee implant devices as follows: Catalog/Product:… — Class II medical device recall Z-2510-2021
Terminated recall by Aesculap Implant Systems LLC, reported 2021-09-29, distributed nationwide. Malfunction- loosening of the implant resulting in a potential revision surgery
| Recall number | Z-2510-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2021-03-19 |
| Classified | 2021-09-22 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2025-03-28 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
Product
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F MENISCAL COMP.T5 RM/LM 8MM; NL481 UNIVATION F MENISCAL COMP.T6 RM/LM 8MM
Reason for recall
Malfunction- loosening of the implant resulting in a potential revision surgery
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2510-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.