Recall Z-0542-2021 ยท LXH Orthopedic Manual Surgical Instrument
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
| Date | Nov 4, 2020 |
| Status | Terminated |
| 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 fro |
| Quantity | 197 units |
| Distribution | Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.