EVEREST Spinal System recallZ-0542-2021 · K2M, Inc · initiated Nov 4, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from K2M, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it 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
FDA root cause category: Process change control
What the company is doing
Stryker issued Urgent Medical Deice Letter dated 11/4/20, stating reason for recall, health risk and action to take: 1. Immediately review the Product Recall Notification. Please forward this information to all sales representatives and operations teams within your Branch/Agency. 2. Immediately check your internal inventory to locate the product listed on the attached Business Reply Form and list the quantity of units on the form. Note: Only the Tab Removal Tools with the Catalog number and Lot numbers specified in the Product Affected Table 1 are in scope of this recall. Tab removal tools from other lots should not be returned. 3. Use the Business Reply Form to reconcile any affected product. Complete the Business Reply Form even if there is no affected product identified. 4. Return the enclosed Business Reply Form by email to [email protected] or fax to 201.575.4675 to confirm receipt of this notification. 5. Within 5 days of receipt of this notice, mail any affected product to: Stryker Spine 610 Hope Parkway SE Leesburg, VA 20175 a. A red return box will be sent to your specified address. b. Please place the returning part in the red box and return the red box inside of the Fed Ex box provided. Pack only the product listed above. c. Use the FedEx label that has been provided to you by Reverse Logistics. d. Appropriately seal the box. Stryker will contact you to arrange for replacement of your product(s). 6. If you desire additional training associated with these instructions, please contact our Regulatory Compliance team at 201.749.8090 or by email at [email protected].
Recall details
- Recall number
- Z-0542-2021
- Status
- Terminated
- Initiated by the company
- Nov 4, 2020
- Recalling firm
- K2M, Inc
- Quantity
- 197 units
- Product code
- LXH
- Distribution
- Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden
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
Code information (models, lots, serial numbers)
Lot Numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR GTIN: 10888857290679
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EVEREST Spinal System 5101-90195VB Spine LLC · Orthopedic manual surgical instrument1 recall46 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page