# FDA recall Z-2514-2021

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

## Product

Univation X System knee implant devices as  follows:  Catalog/Product:  NO156Z  AS UNIVATION XF TIBIA CEMENTED T1 RM;  NO157Z  AS UNIVATION XF TIBIA CEMENTED T2 RM;  NO158Z  AS UNIVATION XF TIBIA CEMENTED T3 RM;  NO159Z  AS UNIVATION XF TIBIA CEMENTED T4 RM;  NO160Z  AS UNIVATION XF TIBIA CEMENTED T5 RM;  NO161Z  AS UNIVATION XF TIBIA CEMENTED T6 RM;  NO162Z  AS UNIVATION XF TIBIA CEMENTED T1 LM;  NO163Z  AS UNIVATION XF TIBIA CEMENTED T2 LM;  NO164Z  AS UNIVATION XF TIBIA CEMENTED T3 LM;  NO165Z  AS UNIVATION XF TIBIA CEMENTED T4 LM;  NO166Z  AS UNIVATION XF TIBIA CEMENTED T5 LM;  NO167Z  AS UNIVATION XF TIBIA CEMENTED T6 LM;

## Reason for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2514-2021
- **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-2514-2021

## Citation

> AI Analytics. FDA recall Z-2514-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2514-2021. Source: US FDA. Licensed CC0.

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