Aesculap Implant Systems LLC: Medical Device Recall in 2021 - (Recall #: Z-2513-2021)

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 knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F MENISCAL COMP.T5 RM/LM 11MM NL499 UNIVATION F MENISCAL COMP.T6 RM/LM 11MM

Product Classification:

Class II

Date Initiated: March 19, 2021

Date Posted: September 29, 2021

Recall Number: Z-2513-2021

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