Class 2 Device Recall Exactech Shoulder GPS Impactor Handle

• Date Initiated by Firm: June 05, 2023
• Date Posted: June 30, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2050-2023
• Recall Event ID: 92414
• 510(K)Number: K173372 K213546
• Product Classification: Orthopedic stereotaxic instrument - Product Code OLO
• Product: Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
• Code Information: Catalog #531-07-05 - Lot numbers: 154287001, 295878002, and 302331004; UDI-DI 10885862542038.
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 Nw 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Kate Jacobson; 352-377-1140
• Manufacturer Reason for Recall: The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
• FDA Determined Cause: Process control
• Action: The recalling firm issued the letters via email to their U.S. agents and OUS on 6/5/2023. The letter explained the reason for recall, risk to health, how to recognize that the device may fail or has failed, the actions being taken by the recalling firm, and the actions to be taken by the customer/user. Regarding the actions being taken by the recalling firm, the letter reported they have implemented a new revision of the impactor handle to eliminate the cause of this event. Upon receipt of the attached Recall Acknowledgement Form, the recalling firm will provide the consignee with new revision parts to replace the recalled devices the consignee has in their inventory. Additionally, the recalling firm updated the Equinoxe Shoulder Operative Techniques to include the statement "WARNING: Do not assemble or disassemble device in the surgical field." The letter contained the links to the two updated operative techniques. Actions to be taken by the customer/user included immediately cease distribution or use of the product and quarantine any of the devices in the consignee's inventory or their customer's inventory and return them back to the recalling firm. The consignee was to provide the recall information to their accounts who may have the product in their possession. The enclosed Recall Inventory Response Form was to be completed and returned to the recalling firm via email. The response form is for the consignee to report they have read and understand the instruction, checked their stock and quarantined inventory, as well as indicating the inventory they are returning, and that they have identified and notified their customers who were shipped or may have been shipped this product.
• Quantity in Commerce: 250 devices
• Distribution: Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, SC, TN, TX, WI, as well as PR. There was no government/military distribution. Foreign distribution was made to Australia, France, and Japan.
• Total Product Life Cycle: TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OLO