Recall Z-2515-2021 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM; NO185Z AS UNIVATION XF FEMUR CEMENTED F1 LM; NO186Z AS UNIVATION XF FEMUR CEMENTED F2 LM; NO187Z
| Date | Mar 19, 2021 |
| Status | Terminated |
| Reason | Malfunction- loosening of the implant resulting in a potential revision surgery |
| Root cause | Unknown/Undetermined by firm |
| Action | Aesulap issued An Urgent Medical Device Recall via USPS overnight to consignees on March 19, 2021. Letter states reason for recall, health risk and action to take: Immediately examine your inventory, identify and quarantine product related to this notification. In addition, if you have further distributed this product, please identify your customers and notify them at once of this Recall Notification. Your notification to your customers may be enhanced by including a copy of this notification letter. A representative of Aesculap will reach out to you to assist in the return of affected produc |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |