K2M Everest MI XT Tab Removal Tool Recalled for Cracking and Leakage
K2M, Inc. is recalling 197 units of the Everest MI XT Tab Removal Tool because the threaded interface may crack, causing Loctite to leak from the handle.
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: The recall involves a medical device with a structural defect (cracking/separating) that could compromise safety, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
K2M, Inc. is recalling 197 units of the Everest MI XT Tab Removal Tool (Catalog number: 5101-90195). The recall covers specific lot numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, and MAJR. The product is distributed nationwide and in the Netherlands, Spain, UK, Belgium, Germany, Italy, Norway, and Sweden.
The recall is being issued because the tool may cause cracking and/or separating at the threaded interface between the tool's metal shaft component and the handle. This defect results in the leakage of Loctite from handle cracks.
Consumers and healthcare providers should stop using the affected tools and contact K2M, Inc. for further instructions or a replacement.
The recalled product
- Product
- Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from the screw head. Catalog number: 5101-90195
- Manufacturer
- K2M, Inc
- Affected units
- 197
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 (7)
- Lot Numbers: JUFT
- JUGX
- KEFE
- KUBJ
- KVNT
- KYRR
- MAJR GTIN: 10888857290679
Distribution
Distributed nationwide across the United States.
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