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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech Equinoxe

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  Class 2 Device Recall Exactech Equinoxe see related information
Date Initiated by Firm March 06, 2024
Date Posted March 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1408-2024
Recall Event ID 94092
510(K)Number K111379  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
a) 38, 41, 44, 47 head, Small, Item Number 314-04-22,
b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23,
c) 44, 47, 50, 53 head, Large, Item Number 314-04-24,
d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-25; Shoulder Arthroplasty
Code Information a) Item Number 314-04-22, UDI/DI 10885862199553, Serial Numbers: 2111946, 2136867, 2136870, 2427405; b) Item Number 314-04-23, UDI/DI 10885862199560, Serial Numbers: 2111953, 2111954, 2139294, 2111955, 2139292, 2139291, 2139288, 2139290, 2424307, 2424304, 2111952, 2424306, 2424314, 2424305, 2482942; c) Item Number 314-04-24, UDI/DI 10885862199577, Serial Numbers: 2111949, 2111950, 2153613, 2153608, 2153607, 2153611, 2153612, 2421997, 2153609, 2421992, 2111951, 2153610, 2421994; d) Item Number 314-04-25, UDI/DI 10885862199584, Serial Numbers: 2112018, 2112019, 2427567
Recalling Firm/
Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Thien Doan
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 2
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 35 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 = KWS and Original Applicant = EXACTECH, INC.