Everest MI XT Outer Dilator — Class II medical device recall Z-0706-2022
Ongoing recall by K2M, Inc, reported 2022-03-09, distributed nationwide. Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting toget
| Recall number | Z-0706-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | K2M, Inc, Leesburg, VA, United States |
| Recall initiated | 2022-01-13 |
| Classified | 2022-03-01 |
| Reported by FDA | 2022-03-09 |
| Distributed | Nationwide (US) |
| Quantity | 686 total |
| UPC / GTIN / UDI-DI | 10888857261211 |
| Model numbers | 5101-90168 |
Product
Everest MI XT Outer Dilator, Catalog Number 5101-90168
Reason for recall
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
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-0706-2022. 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.