# FDA recall Z-2515-2021

> **Aesculap Implant Systems LLC** · Class II · device recall initiated 2021-03-19.

## Product

Univation X System knee implant devices as  follows:  Catalog/Product:  NO180Z  AS UNIVATION XF FEMUR CEMENTED F1 RM;  NO181Z  AS UNIVATION XF FEMUR CEMENTED F2 RM;  NO182Z  AS UNIVATION XF FEMUR CEMENTED F3 RM;  NO183Z  AS UNIVATION XF FEMUR CEMENTED F4 RM;  NO184Z  AS UNIVATION XF FEMUR CEMENTED F5 RM;  NO185Z  AS UNIVATION XF FEMUR CEMENTED F1 LM;  NO186Z  AS UNIVATION XF FEMUR CEMENTED F2 LM;  NO187Z  AS UNIVATION XF FEMUR CEMENTED F3 LM;  NO188Z  AS UNIVATION XF FEMUR CEMENTED F4 LM;  NO189Z  AS UNIVATION XF FEMUR CEMENTED F5 LM

## Reason for recall

Malfunction- loosening of the implant resulting in a potential revision surgery

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2515-2021
- **Recalling firm:** Aesculap Implant Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-19
- **Report date:** 2021-09-29
- **Termination date:** 2025-03-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2515-2021

## Citation

> AI Analytics. FDA recall Z-2515-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2515-2021. Source: US FDA. Licensed CC0.

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