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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker EVEREST Spinal System

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 Class 2 Device Recall Stryker EVEREST Spinal Systemsee related information
Date Initiated by FirmNovember 04, 2020
Create DateDecember 07, 2020
Recall Status1 Terminated 3 on February 22, 2024
Recall NumberZ-0542-2021
Recall Event ID 86733
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductEverest 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 Lot Numbers:  JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR  GTIN: 10888857290679
FEI Number 3008599177
Recalling Firm/
Manufacturer		 K2M, Inc
600 Hope Pkwy SE
Leesburg VA 20175-4428
Manufacturer 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 Determined
Cause 2		Process change control
ActionStryker 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 in Commerce197 units
DistributionNationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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