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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 November 21, 2023
Date Posted January 18, 2024
Recall Status1 Open3, Classified
Recall Number Z-0580-2024
Recall Event ID 93507
510(K)Number K212356  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Exactech Equinoxe Shoulder System, Catalog Numbers:
a) 314-23-02,
b) 314-23-03,
c) 314-23-13,
d) 314-23-14,
e) 314-23-15,
f) 314-24-22,
g) 314-24-23,
h) 314-24-24,
i) 314-24-32,
j) 314-24-33,
k) 314-24-34,
l) 314-24-35
Code Information a) 314-23-02, GTIN 10885862585288, Serial Numbers: A644041, A644042, A644043, A644044, A660121, A660122, A660124, A662676, A662681, A662684, A662685, A662688, A680284, A680285, A680288, A680289; b) 314-23-03, GTIN 10885862585295, Serial Numbers: A705013, A705015, A705017, A705019, A724643, A724644, A724645, A724649, A724650, A724653, A724654, A724655, A724660, A724662, A724664; c) 314-23-13, GTIN 10885862585318, Serial Numbers: A641342, A641343, A641348, A659643, A659645, A662713, A662714, A662715, A662716, A662717, A662718, A662722, A662728, A724502, A724505, A724509, A724512, A724519, A724520, A724521, A724522, A724529, A724531, A724535, A724542, A737352, A737356; d) 314-23-14, GTIN 10885862585325, Serial Numbers: A644055, A644056, A644057, A649227, A649231, A659611, A662730, A662731, A662732, A662733, A662734, A662736, A662737, A662743, A662744, A662745, A737404, A737408; e) 314-23-15, GTIN 10885862585332, Serial Numbers: A644011, A644012, A644013, A644015, A649151, A649157, A649158, A649160, A649161, A649162, A649164, A649165, A659613, A659614, A659615, A659616, A659617, A659620, A659622; f) 314-24-22, GTIN 10885862585349, Serial Numbers: A662708, A704921, A704924, A708554, A708559, A708560, A737109, A737114, A737115, A737117; g) 314-24-23, GTIN 10885862585356, Serial Numbers: A680327, A704932, A704936, A704939, A704941, A704943, A704945; h) 314-24-24, GTIN 10885862585363, Serial Numbers: A697922, A697923, A697928, A704996, A704997, A704998, A704999, A705000, A705001, A705002, A705003, A705004, A705005, A705007, A705009, A705011, A737098; i) 314-24-32, GTIN 10885862585387, Serial Numbers: A660114, A691515, A691522, A708328; j) 314-24-33, GTIN 10885862585394, Serial Numbers: A660130, A660135, A660137, A660139, A660140, A704661, A704662, A704665, A704667; k) 314-24-34, GTIN 10885862585400, Serial Numbers: A649166, A649168, A649169, A649170, A649175, A662702; l) 314-24-35, GTIN 10885862585417, Serial Numbers: A659658, A659663
Recalling Firm/
Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
Manufacturer Reason
for Recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
FDA Determined
Cause 2
Packaging change control
Action Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.
Distribution US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
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.