CLASS II ONGOING Device recall · Reported 26 Jun 2024 · FDA Enforcement Report
Optetrak One Peg Patella recalled by Exactech
Exactech is recalling Optetrak One Peg Patella. The recall was initiated on 18 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2156-2024
- FDA event ID
- 94409
- Recalling firm
- Exactech, Gainesville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Apr 2024
- FDA classified
- 18 Jun 2024
- Reported
- 26 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 18 Apr 2024 | Recall initiated by company | |
| 18 Jun 2024 | Classified by FDA | +61 days |
| 26 Jun 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution.
Questions about this recall
Is Optetrak One Peg Patella recalled?
Yes. Exactech recalled Optetrak One Peg Patella on 18 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-2156-2024.
Why was it recalled?
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Which lots are affected?
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
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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