Reported Jun 26, 2024 · Ongoing
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,…
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
200-03-26 | OPTETRAK One Peg Patella,, Item Numbers: a) |
200-03-29 | 26MM; b) |
200-03-32 | 29MM; c) |
200-03-35 | 32MM; d) |
200-03-38 | 35MM; e) |
200-03-41 | 38MM; f) |
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 10885862039637200-03-26, UDI/DI 10885862039637, Lot Numbers: 6389536, 6389549, 6389551, 6389538, 6389540, 6389531, 6389537, 6389529, 6389534, 6389542, 6389545, 6711546, 6711550, 6389547, 6389548, 6389555, 6711540 2 10885862039644200-03-29, 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 3 10885862039651200-03-32, 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 4 10885862039668200-03-35, UDI/DI 10885862039668, Lot Numbers: 6711235, 6711254, 7044342, 7044351, 7044345, 6711236, 6711253, 7044338, 7044347, 7044349, 7044348, 6711245, 7044352, 7044336, 7044350 5 10885862039675200-03-38, 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 6 10885862039682200-03-41, UDI/DI 10885862039682, Lot Numbers: 6389208, 6389211, 6389221, 6389216, 6389215, 6389220, 6389225, 6389213, 6389223, 6389224, 6389217, 6389226, 6389210, 6389222, 6389214, 6389207, 6389212, 6389219 - Amount recalled
- N/A
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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