OPTETRAK, 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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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:
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Exactech, Inc.
- Reason for Recall:
- Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
OPTETRAK, 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
Product Codes/Lot Numbers:
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:
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2158-2024
Related Recalls
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.