Recall Z-2511-2021— Aesculap Implant Systems LLC

Name: FDA recall Z-2511-2021
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 knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM; NL484 UNIVATION F MENISCAL COMP.T3 RM/LM 9MM; NL485 UNIVATION F MENISCAL COMP.T4 RM/LM 9MM; NL486 UNIVATION F MENISCAL COMP.T5 RM/LM 9MM; NL487 UNIVATION F MENISCAL COMP.T6 RM/LM 9MM. 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 knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM; NL484 UNIVATION F MENISCAL COMP.T3 RM/LM 9MM; NL485 UNIVATION F MENISCAL COMP.T4 RM/LM 9MM; NL486 UNIVATION F MENISCAL COMP.T5 RM/LM 9MM; NL487 UNIVATION F MENISCAL COMP.T6 RM/LM 9MM

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.