Recall Z-2514-2021 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: 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
| 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 |