FDA Device recall Z-2511-2021
Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM
- FDA Device
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM by Aesculap Implant Systems, citing malfunction- loosening of the implant resulting in a potential revision surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2511-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-19 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aesculap Implant Systems |
| Distribution | US |
Product
Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM; NL484 UNIVATION F MENISCAL COMP.T3 RM/LM 9MM; NL485 UNIVATION F MENISCAL COMP.T4 RM/LM 9MM; NL486 UNIVATION F MENISCAL COMP.T5 RM/LM 9MM; NL487 UNIVATION F MENISCAL COMP.T6 RM/LM 9MM
Reason
Malfunction- loosening of the implant resulting in a potential revision surgery
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2511-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.