OPTETRAK Three Peg Patella recall
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;
Why was OPTETRAK Three Peg Patella recalled?
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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;
- Recalling firm
- Exactech, Inc.
- Quantity
- N/A
- Distribution
- Worldwide distribution.
- Recall date
- June 26, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)