Aesculap Implant Systems LLC: Medical Device Recall in 2021 - (Recall #: Z-2516-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: March 19, 2021

Date Posted: September 29, 2021

Recall Number: Z-2516-2021

Event ID: 88325

Reason for Recall:

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

Status: Terminated

Product Quantity:

Code Information:

All lots

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated