Recall Z-2514-2021— Aesculap Implant Systems LLC

Name: FDA recall Z-2514-2021
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: 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;. 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: 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;

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.