Z-0580-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2023
- Initiation Date
- November 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
Reason for Recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Distribution Pattern
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
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