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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2510-2021 |
| Event ID | 88325 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Recall Reason | Malfunction- loosening of the implant resulting in a potential revision surgery |
| Device Classification | 20210929 |
| Device Code Info | All lots |
| Center Classification Date | 20210922 |
| Recall Initiation Date | 20210319 |
| Recalling Firm | Aesculap Implant Systems LLC |
| Initial Notification | Letter |
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