Aesculap Implant Systems LLC Recall 88325
Description: Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F MENISCAL COMP.T5 RM/LM 7MM NL475 UNIVATION F MENISCAL COMP.T6 RM/LM 7MM
Aesculap Implant Systems LLC Recall 88325 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2509-2021 |
| Event ID | 88325 |
| Event Description | Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F MENISCAL COMP.T5 RM/LM 7MM NL475 UNIVATION F MENISCAL COMP.T6 RM/LM 7MM |
| 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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