Aesculap Implant Systems LLC: Medical Device Recall in 2021 - (Recall #: Z-2514-2021)

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: 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;

Product Classification:

Class II

Date Initiated: March 19, 2021

Date Posted: September 29, 2021

Recall Number: Z-2514-2021

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