Class 2 Device Recall Exactech Equinoxe

• Date Initiated by Firm: March 06, 2024
• Date Posted: March 29, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1419-2024
• Recall Event ID: 94092
• 510(K)Number: K063569
• Product Classification: shoulder prosthesis, reverse configuration - Product Code PHX
• Product: Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: ; a) +0mm, Item Number 320-38-10, ; b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
• Code Information: a) Item Number 320-38-10, UDI/DI 10885862086679, Serial Numbers: 0982088, 0982095, 1035622, 0982086, 1035885, 0982078, 1035878, 1035894, 1036369, 1036373, 1013872, 1013887, 1035623, 1035875, 1035880, 1035881, 1035883, 1119110, 1119136, 1119124, 1119130, 1119144, 1119109, 1119104, 1119123, 1119128, 1119129, 1119146, 1036368, 0982100, 1013871, 1013874, 1074102, 1035619, 1013884, 1035629, 1074121, 1035889, 1035876, 1036374, 1074138, 1035893, 1013886, 1035624, 1074108, 1074122, 1074127, 1074128, 1074139, 1035882, 1036366, 0982084, 1374085, 1119094, 1119102, 0982089, 0982081, 1074131, 0982101, 1036359, 1036364, 1074120, 0982087, 1074147, 1074109, 1442856, 1416801, 1416805, 1374050, 1545547, 1374052, 1416803, 1545546, 1374079, 1374342, 1374339, 1374347, 1416802, 1374077, 1374355, 1416811, 1505058, 1505060, 1442866, 1505054, 1516382, 1516384, 1374351, 1505050, 1516381, 1374043, 1516390, 1119121, 1119127, 1119119, 1119145, 1119098, 1119143, 1074119, 0982090, 1074137, 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• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 Nw 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Thien Doan ; 352-377-1140
• Manufacturer Reason for Recall: The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
• FDA Determined Cause: Nonconforming Material/Component
• Action: Beginning 03/06/2024, Exactech issued an URGENT MEDICAL DEVICE RECALL notice and an URGENT DEAR HEALTHCARE PROFESSIONAL COMMUNICATION to its consignees via email. The recall notice explained the issue, clinical impact, and requested the following actions be taken: "" CAREFULLY REVIEW THIS RECALL NOTIFICATION to ensure that you fully understand the issue identified, the recall strategy, and all actions required. " IMMEDIATELY IDENTIFY AND QUARANTINE any of the subject devices in your inventory and/or customer s inventory listed Product Scope Listing. " EXTEND THE DESCRIPTION OF ISSUE AND CLINICAL IMPACT as described in the recall notification to your accounts that may have this product in their possession. " COMPLETE AND RETURN the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com. The communication to healthcare providers referenced the FDA Safety Communication issued on 01/16/2024, explained the issue, potential health risks, and suggested patient monitoring for those with implanted affected devices for potential device wear, failure, or bone loss and should consider performing X-rays to further evaluate the patient and their implanted device if you suspect a failed device. Contact your local Exactech Representative if you have any questions regarding this communication.
• Quantity in Commerce: 7213 units
• Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
• 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 = PHX and Original Applicant = EXACTECH, INC.