OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) 200-03-26, UDI/DI 10885862039637, Lot Numbers: 6389536, 6389549, 6389551, 6389538, 6389540, 6389531, 6389537, 6389529, 6389534, 6389542, 6389545, 6711546, 6711550, 6389547, 6389548, 6389555, 6711540; b) 200-03-29, UDI/DI 10885862039644, Lot Numbers: 6276447, 6276452, 6385318, 6385319, 6607740, 6385323, 6385304, 6385321, 6276446, 6276448, 6385300, 6276442, 6385310, 6385316, 6385325, 6607741, 7037109, 6276425, 6276429, 6276428, 6276433, 6276450, 6276453, 6607760, 6276437, 6276440, 6607751, 6607754, 6276426, 6276445, 6276449, 6607744, 6607759, 6276434, 6276435, 6276443, 6276451, 6385307; c) 200-03-32, UDI/DI 10885862039651, Lot Numbers: 6385285, 6385286, 6844803, 6844831, 6385268, 6385278, 7043349, 7043358, 7043331, 6844822, 6385266, 6385269, 6385272, 6385277, 6385274, 7043330, 7043333, 7043336, 7043337, 7043342, 7043343, 7043356, 6385273, 6385281, 6385294, 6844804, 6844817, 6844818, 6844826; d) 200-03-35, UDI/DI 10885862039668, Lot Numbers: 6711235, 6711254, 7044342, 7044351, 7044345, 6711236, 6711253, 7044338, 7044347, 7044349, 7044348, 6711245, 7044352, 7044336, 7044350; e) 200-03-38, UDI/DI 10885862039675, Lot Numbers: 6401867, 6401876, 6401870, 7043457, 6401882, 6401868, 6401871, 7043466, 7043474, 6401858, 6401872, 7043460, 6923186, 6401873, 6923184, 6401855, 6401860, 6401877, 6401879, 7043459, 7043463; f) 200-03-41, UDI/DI 10885862039682, Lot Numbers: 6389208, 6389211, 6389221, 6389216, 6389215, 6389220, 6389225, 6389213, 6389223, 6389224, 6389217, 6389226, 6389210, 6389222, 6389214, 6389207, 6389212, 6389219
- 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 One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
Product Codes/Lot Numbers:
a) 200-03-26, UDI/DI 10885862039637, Lot Numbers: 6389536, 6389549, 6389551, 6389538, 6389540, 6389531, 6389537, 6389529, 6389534, 6389542, 6389545, 6711546, 6711550, 6389547, 6389548, 6389555, 6711540; b) 200-03-29, UDI/DI 10885862039644, Lot Numbers: 6276447, 6276452, 6385318, 6385319, 6607740, 6385323, 6385304, 6385321, 6276446, 6276448, 6385300, 6276442, 6385310, 6385316, 6385325, 6607741, 7037109, 6276425, 6276429, 6276428, 6276433, 6276450, 6276453, 6607760, 6276437, 6276440, 6607751, 6607754, 6276426, 6276445, 6276449, 6607744, 6607759, 6276434, 6276435, 6276443, 6276451, 6385307; c) 200-03-32, UDI/DI 10885862039651, Lot Numbers: 6385285, 6385286, 6844803, 6844831, 6385268, 6385278, 7043349, 7043358, 7043331, 6844822, 6385266, 6385269, 6385272, 6385277, 6385274, 7043330, 7043333, 7043336, 7043337, 7043342, 7043343, 7043356, 6385273, 6385281, 6385294, 6844804, 6844817, 6844818, 6844826; d) 200-03-35, UDI/DI 10885862039668, Lot Numbers: 6711235, 6711254, 7044342, 7044351, 7044345, 6711236, 6711253, 7044338, 7044347, 7044349, 7044348, 6711245, 7044352, 7044336, 7044350; e) 200-03-38, UDI/DI 10885862039675, Lot Numbers: 6401867, 6401876, 6401870, 7043457, 6401882, 6401868, 6401871, 7043466, 7043474, 6401858, 6401872, 7043460, 6923186, 6401873, 6923184, 6401855, 6401860, 6401877, 6401879, 7043459, 7043463; f) 200-03-41, UDI/DI 10885862039682, Lot Numbers: 6389208, 6389211, 6389221, 6389216, 6389215, 6389220, 6389225, 6389213, 6389223, 6389224, 6389217, 6389226, 6389210, 6389222, 6389214, 6389207, 6389212, 6389219
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2156-2024
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.