Class 2 Device Recall OPTETRAK

• Date Initiated by Firm: April 18, 2024
• Date Posted: June 18, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2155-2024
• Recall Event ID: 94409
• 510(K)Number: K160484 K932690 K933610
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM
• Code Information: a) 200-02-26, UDI/DI 10885862039576, Lot Numbers: 5881807, 5908515, 5968530, 6007309, 6038708, 6038717, 6066779, 6345487, 6345502, 6358520, 6431224, 6431231, 6551547, 6557360, 6723682, 6734364, 6771158, 6865729, 6910696, 6910715, 6910718, 6910745, 6910752, 6910779, 7017876, 5968531, 6161207, 6383171, 6358523, 6601196, 6910805, 6066775, 6424212, 6431232, 7017878, 6406114, 6601148, 6161158, 6161182, 6470948, 6470955, 5968547, 6004184, 6383177, 6514106, 6551513, 6551531, 6551534, 6601150, 6672159, 6723663, 6723679, 6910704, 6007300, 6007323, 6007306, 6383158, 6181021, 6530351, 6530359, 6910787, 6514153, 6557339, 6557341, 6066789, 6457006, 6007299, 6530338, 6601188, 6621896, 6672158, 6865746, 6910794, 6004190, 6601141, 6601180, 6716699, 6716716, 7017894, 6038704, 6038713, 6457023, 6530356, 6668072, 6672152, 6723670, 6723690, 6038746, 6203999, 6371789, 6371797, 6371819, 6424210, 6431226, 6601165, 6601181, 6601195, 6672143, 6672148, 6734373, 6865718, 6865731, 6865736, 6865748, 6865750, 6910758, 6910759, 6910761, 6910778, 6910788, 7017895; b) 200-02-29, UDI/DI 10885862039583, Lot Numbers: 5879069, 6007378, 6007384, 6160756, 6160758, 6516483, 6530381, 6530425, 6631144, 6666877, 6666893, 6716571, 6716613, 6721823, 6741812, 6857688, 6919108, 6083494, 6530382, 6555638, 6979180, 6005908, 6005941, 6160736, 6160755, 6516968, 6559612, 6673204, 6803850, 6881661, 6110574, 6160509, 6982513, 6555598, 6555750, 5901678, 6530553, 6530562, 6709794, 6866198, 6530428, 6530534, 6530571, 6631384, 6725048, 6918774, 6206453, 6516950, 6530404, 6530546, 6559642, 6559778, 6673145, 6784688, 6784711, 6784717, 6005907, 6007171, 5878953, 6160760, 6160765, 6206455, 6530391, 6530422, 6555026, 6555618, 6559733, 6643090, 6666889, 6709806, 6721849, 6736483, 6848341, 6910605, 6918890, 6981879; c) 200-02-32, UDI/DI 10885862039590, Lot Numbers: 5865261, 6066890, 6529343, 6636250, 6646113, 6741660, 6812750, 6832689, 6631118, 6646171, 6897705, 6036281, 6046542, 6774341, 6776375, 6776465, 6161541, 6457699, 6470232, 6529411, 6621368, 6631108, 6636243, 6457685, 6857923, 6866377, 6529386, 6621380, 6646184, 6162074, 6162084, 6532564, 6551720, 6897690, 6092331, 6204036, 5879200, 6621788, 6646177, 6776406, 6812673, 6590081, 6636222, 6671944, 6776390, 6812686, 6882843, 6086424, 6110447, 6499773, 6502538, 6502542, 6607208, 6741649, 6784543, 6898355; d) 200-02-35, UDI/DI 10885862039606, Lot Numbers: 6083434, 6083438, 6331762, 6515586, 6645576, 6756391, 6869962, 6986421, 7035009, 5886784, 6547109, 6631290, 6860839, 6083417, 6162448, 6162466, 6607099, 6630977, 6643152, 6645564, 6724011, 6560456, 6896425, 6896845, 6813363, 6417511, 6981313, 6668734, 6986410, 6187587, 6896453, 6560529, 6784601, 6003738, 6043752, 6560452, 6982298, 6645561, 6038659, 6044116, 6547166, 6709766, 6741638, 6784626, 6897269, 6982290, 6066900, 6066904, 6593133, 6716418, 6813380, 6856198, 6043758, 6043759, 6502461, 6502477, 6528571, 6860793, 6869996, 6897321, 6919031; e) 200-02-38, UDI/DI 10885862039613, Lot Numbers: 5908394, 5956763, 6007401, 6162652, 6162653, 6499738, 6562077, 6562880, 6607038, 6630515, 6710008, 6840536, 6840547, 6850839, 6850845, 6910559, 6910564, 6007417, 6667841, 6529888, 6840542, 6774457, 6981964, 6667868, 6162628, 6162676, 6382287, 6562053, 6562849, 6607011, 6621318, 6305341, 6382295, 6405731, 6499710, 6740028, 6840242, 6188399, 6162629, 6162639, 6607029, 6896385, 6981923, 6003469, 6740033, 6774460, 6981928, 6562023, 6606987, 6866541, 6621336, 6840240, 5956757, 6039164, 6162684, 6204860, 6499730, 6562812, 6850866, 6866540, 6866543, 6882197, 6910516, 6067850, 6067855, 6067858, 6162664, 6436339, 6709992, 6740067, 6840554, 6043133, 6043150, 6086648, 6162656, 6384369, 6384557, 6384577, 6646847, 6751532, 6840265, 6840278, 6882233, 6896358, 6910557, 6981971; f) 200-02-41, UDI/DI 10885862039620, Lot Numbers: 5914786, 5956785, 5956787, 6012382, 6012386, 6038392, 6083318, 6083326, 6083330, 6083337, 6219023, 6458802, 6522923, 6547557, 6547587, 6646426, 6755032, 6755053, 6901014, 6936833, 6936863, 6936880, 6936886, 6623181, 6672079, 6901034, 6936879, 6083333, 6185479, 6561274, 6777289, 6012395, 6219030, 6436362, 6623186, 6801028, 6801025, 6801046, 6012363, 6012364, 6012405, 6853482, 5956792, 6083311, 6083320, 6522950, 6672071, 6219019, 6458795, 6458808, 6522947, 6561273, 6646421, 6646437, 6853491, 6900982, 6936850, 6623169, 6646416, 6901002, 6083327, 6547566, 6522932, 6561261, 6623170, 6547591, 6672097, 6853493, 6458807, 6522931, 6547613, 6561272, 6672082, 6777287, 6083347, 6646431, 6801037, 5956800, 6012361, 6012411, 6012415, 6206361, 6646428, 6801019, 6801034, 6801048, 6853485, 6522926, 6561254, 6721787, 6801023, 6801027, 6801029, 6801031, 6853477, 6853478, 6853480, 6936842, 5956798, 5956958, 6038367, 6038389, 6083335, 6162381, 6185492, 6206350, 6206353, 6206366, 6219022, 6219029, 6458793, 6547583, 6646440, 6672098, 6721794, 6755043, 6801045, 6853476, 6901000, 6901007, 6901016
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 Nw 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: 352-377-1140
• Manufacturer Reason for Recall: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
• FDA Determined Cause: Under Investigation by firm
• Action: Exactech issued an URGENT VOLUNTARY MEDICAL DEVICE RECALL to its sales representatives on 04/12/2024. The notice explained the issue with the device, clinical impact (risk), and requested the following: Actions to be Taken " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Send all affected product back to Exactech as outlined in the attached Recall Confirmation Form . The firm notified the surgeons, hospitals, and healthcare professionals on 04/18/2024. That notice also explained the issue, clinical impact (risk) and requested the following: Actions to be Taken " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Contact your Exactech Representative. Your local agent will help determine if you have any remaining affected product and remove from your inventory.
• Distribution: Worldwide distribution.
• 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 = JWH; 510(K)s with Product Code = JWH