Recall record at a glance
| Official record | Z-0542-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | K2M, Inc. |
| Report date | Dec 16, 2020 |
| Recall initiation date | Nov 4, 2020 |
| Quantity | 197 units |
| Location | Leesburg, VA, United States |
Official product description
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
Why the product was recalled
All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks
Distribution information
Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.