Everest MI XT Inner Dilator, Catalog Number 5101-90167
Check against the official notice below — it lists the full affected range.
K2M, Inc. is recalling the Everest MI XT Inner Dilator (Catalog Number 5101-90167) due to a manufacturing defect affecting 686 devices distributed worldwide and across the United States. Stryker received two complaints about inner and outer dilators from specific lot numbers that did not fit together properly during surgical procedures. Testing subsequently identified a manufacturing nonconformance affecting dilators from these and other lot numbers, including those with lot codes JUJF, KFMV, KUPG, KYYU, MDRB, NDMK, NDMX, and NXJK.
The source document does not specify a remedy or instructions for affected consumers regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide distribution - US Nationwide. Quantity: 686 Total Devices Lot/code info: GTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.