Recall Z-0542-2021

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: Process change control

Action taken

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.