FDA Medical Device Recalls (openFDA)
K2M, Inc: 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
- Recall number
- Z-0542-2021
- Recalling firm
- K2M, Inc
- 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
- Status
- Terminated
- Initiated
- 2020-11-04
- Posted
- not on file
- Terminated
- 2024-02-22
- Reason
- 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
- Root cause
- Process change control
- Action
- 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 Spine-RegulatoryActions@Stryker.com 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 Spine-RegulatoryActions@Stryker.com.
- Quantity
- 197 units
- Distribution
- Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden
- Lot, serial or model codes
- Lot Numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR GTIN: 10888857290679
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3008599177
- Firm city
- Leesburg
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28