Z-0542-2021Class II

Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT...

Name: Z-0542-2021 Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT...
Creator: K2M, Inc
Published: 2020-11-04
License: https://open.fda.gov/license/

K2M, Inc / initiated 2020-11-04 / Terminated

FDA source

K2M, Inc began a recall of 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... on 2020-11-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0542-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-04
Posted: 2020-12-07
Terminated: 2024-02-22
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
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: 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: 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 [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].
Quantity in commerce: 197 units
Distribution: Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden
Product codes and lots: Lot Numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR GTIN: 10888857290679

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0542-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0542-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-07

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)