Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Univation X System Tray Sysem knee implant devices as follows: Recalled by Aesculap Implant Systems LLC Due to Malfunction- loosening of the implant resulting in a...

Date: March 19, 2021
Company: Aesculap Implant Systems LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Aesculap Implant Systems LLC directly.

Affected Products

Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Aesculap Implant Systems LLC

Aesculap Implant Systems LLC has 61 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report