K2M Everest MI XT Inner Dilator Recalled for Manufacturing Fit Defect
K2M recalled 686 units of the Everest MI XT Inner Dilator due to a manufacturing nonconformance preventing proper fit with outer dilators during surgery. Two complaints prompted the recall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device with a confirmed manufacturing nonconformance that prevents proper function during surgical procedures, classifying it as a risk-of-harm product. However, no injuries or illnesses have been reported in the source material.
Plain-English summary
K2M, Inc. manufactures the Everest MI XT Inner Dilator (Catalog Number 5101-90167), a surgical instrument used in medical procedures. The company has recalled 686 units due to a manufacturing nonconformance affecting the device's fit with outer dilators. The affected products are distributed worldwide and across the United States.
Two complaints were received regarding Inner and Outer Dilators not fitting together properly during surgical procedures. Investigation confirmed that a manufacturing nonconformance was present in dilators from specific lots and other affected lots. The defect prevents proper fit between the inner and outer components of the surgical instrument.
Affected lot numbers include JUJF, KFMV, KUPG, KYYU, MDRB, NDMK, NDMX, and NXJK. Patients who have undergone procedures using this device and healthcare providers with these products should contact K2M for guidance regarding the recall.
The recalled product
- Product
- Everest MI XT Inner Dilator, Catalog Number 5101-90167
- Manufacturer
- K2M, Inc
- Category
- Medical Device
- Affected units
- 686
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN: 10888857261204
- Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by K2M, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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