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Aesculap Implant Systems LLC Recall 88325

Description: 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

Aesculap Implant Systems LLC Recall 88325 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2510-2021
Event ID88325
Event DescriptionUnivation 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
Product TypeDevices
DistributionUS Nationwide distribution.
Recall ReasonMalfunction- loosening of the implant resulting in a potential revision surgery
Device Classification20210929
Device Code InfoAll lots
Center Classification Date20210922
Recall Initiation Date20210319
Recalling FirmAesculap Implant Systems LLC
Initial Notification Letter
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