FDA Device recall Z-1391-2022
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant…
- FDA Device
- Class II
- completed
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant… by Aesculap Implant Systems, citing nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1391-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-11-12 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aesculap Implant Systems |
| Distribution | US |
Product
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Reason
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Identifiers
| code_info | UDI-DI (GTIN): 04046963419639 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1391-2022%22
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