FDA recall Z-2510-2021

Product

Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F MENISCAL COMP.T5 RM/LM 8MM; NL481 UNIVATION F MENISCAL COMP.T6 RM/LM 8MM

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2021-03-19

Report date

2021-09-29

Termination date

2025-03-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2510-2021