Recall Z-2516-2021— Aesculap Implant Systems LLC

Name: FDA recall Z-2516-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-19

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2021-03-19, terminated 2025-03-28. It names 2 FDA 510(k) clearances: K131167, K081293. Product: 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. Reason: Malfunction- loosening of the implant resulting in a potential revision surgery.

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2021-03-19
Terminated: 2025-03-28
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K131167 — UNIVATIONAesculap Implant Systems, LLC·cleared 2013-10-17
K081293 — UNIVATION UNICONDYLAR KNEE SYSTEMAesculap Implant Systems, Inc.·cleared 2008-09-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.