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U.S. Department of Health and Human Services

Class 2 Device Recall OPTETRAK

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 Class 2 Device Recall OPTETRAKsee related information
Date Initiated by FirmApril 18, 2024
Date PostedJune 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2158-2024
Recall Event ID 94409
510(K)NumberK160484 K932690 K933610 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductOPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
Code Information a) 200-07-26, UDI/DI 10885862314260, Lot Numbers: 5937497, 6015804, 6038627, 6038629, 6038631, 6067823, 6067835, 6067836, 6305296, 6305298, 6305299, 6535789, 6535803, 6535805, 6535809, 6590076, 6645243, 6673338, 6786230, 6786240, 6786241, 6535796, 6535800, 6535816, 6645242, 6786226, 6038630, 6535815, 6645241, 6739854, 6673345, 6535784, 6645237, 6739847, 6786239, 6535791, 6535797, 6535801, 6535814, 6535813, 6535818, 6590073, 6590075, 6535785, 6535793, 6786235, 6786236, 6015801, 6038621, 6038623, 6038634, 6535799, 6590070, 6739858, 6015793, 6067825, 6305288, 6305297, 6535783, 6535819, 6590071, 6739843, 6739855, 6739860, 6786225, 6786228; b) 200-07-29, UDI/DI 10885862314277, Lot Numbers: 6645889, 6772402, 6533499, 6752332, 6772396, 6832365, 6982420, 6323576, 6832362, 6832369, 7011431, 6549464, 6208480, 6645945, 6865835, 6865866, 6316340, 7044556, 6533462, 6856163, 6866305, 7011384, 7011417, 7044569, 7044578, 6777243, 7057281, 6982471, 7011389, 7011418, 7044584, 6772382, 6866307, 7057296, 6406015, 6524753, 6533476, 6606329, 6606332, 6672745, 6730135, 6749434, 6749437, 6749481, 6865871, 7011383; c) 200-07-32, UDI/DI 10885862314284, Lot Numbers: 6643242, 6011209, 6896812, 6504988, 6747994, 6643251, 7057358, 6504922, 6896823, 6012456, 6311777, 6516256, 6516259, 6606125, 6771958, 6965420, 7009622, 7057577, 7057703; d) 200-07-35, UDI/DI 10885862314291, Lot Numbers: 6910903, 6385204, 6524726, 6540451, 6853437, 6853455, 6973342, 7031138, 6385363, 6524696, 6606620, 6672470, 6754472, 6754523, 7031154, 7031155, 6524722, 6621734, 7004924, 6606280, 7044376, 6054711, 6973348, 6536461, 6540445, 6590022, 6738250, 6910891, 6041100, 6524685, 6524708, 6606631, 6621723, 6646277, 6646284, 6752047, 6801191, 6814395, 6853451, 6897017, 7044357; e) 200-07-38, UDI/DI 10885862314307, Lot Numbers:
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 2		Under Investigation by firm
ActionExactech 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.
DistributionWorldwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
510(K)s with Product Code = JWH
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