Device product
Everest MI XT Outer Dilator, Catalog Number 5101-90168
Z-0706-2022
Product summary
- Firm
- K2M, Inc
- Event
- Event 89522
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 686 Total Devices
- Official record key
device-enforcement:Z-0706-2022
Official wording
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.
Code information: GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN
Distribution pattern: Worldwide distribution - US Nationwide.
Derived failure modes
-
Manufacturing or process control
manufacturing nonconformance