medical Class II Updated 2022-03-09

K2M, Inc recalls Everest MI XT Outer Dilator, Catalog Number 5101-90168

Recalled Product

Everest MI XT Outer Dilator, Catalog Number 5101-90168

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN
View official government recall

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