ENDURO SPECIAL KEY TIB — Class II medical device recall Z-1391-2022
Completed recall by Aesculap Implant Systems LLC, reported 2022-07-27, distributed nationwide. Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the
| Recall number | Z-1391-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2019-11-12 |
| Classified | 2022-07-15 |
| Reported by FDA | 2022-07-27 |
| Distributed | Nationwide (US) |
| Quantity | 67 |
| UPC / GTIN / UDI-DI | 04046963419639 |
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 for recall
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1391-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.