FDA Device recall Z-0706-2022
Everest MI XT Outer Dilator, Catalog Number 5101-90168
- FDA Device
- Class II
- ongoing
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of Everest MI XT Outer Dilator, Catalog Number 5101-90168 by K2m, citing 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 lo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0706-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-13 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | K2m |
| Distribution | US |
Product
Everest MI XT Outer Dilator, Catalog Number 5101-90168
Reason
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.
Identifiers
| code_info | GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0706-2022%22
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