Class 2 Device Recall Exactech Connexion

• Date Initiated by Firm: June 29, 2021
• Date Posted: July 22, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2115-2021
• Recall Event ID: 88126
• 510(K)Number: K100269
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant component.
• Code Information: All serial numbers. UDI-DI number: 10885862021892
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 Nw 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Mr. Nicholas Bennett; 800-392-2832
• Manufacturer Reason for Recall: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: The firm issued "URGENT MEDICAL DEVICE CORRECTION" letters dated 6/28/2021 via email on 6/29/2021 that were addressed to the attention of Exactech Agents, Representatives, and Distributors in possession of affected products.
• Quantity in Commerce: 89,050 total
• Distribution: Distribution US nationwide.
• 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 = LPH