Orthopedic Knee Implants Lack Protective Oxygen Barrier in Packaging
Exactech OPTETRAK Comprehensive Knee System inserts were packaged in vacuum bags lacking an additional oxygen barrier layer, which could allow material degradation. The recall affects 2,774 devices distributed worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall of a packaging defect without reported illnesses or injuries in the source material. The hazard is precautionary—missing oxygen barrier in vacuum bags—with no documented device failures.
Plain-English summary
The FDA has recalled the OPTETRAK Comprehensive Knee System, including all-polyethylene UNI Tibial Components manufactured by Exactech, Inc. This Class II recall affects 2,774 orthopedic knee implants.
The inserts were packaged in vacuum bags lacking an additional oxygen barrier layer. This packaging defect is the reason for the recall.
The affected devices were distributed worldwide, including throughout the United States and to more than 40 countries. Patients who received these implants should contact their surgeon or healthcare provider if they have any concerns about their device.
The recalled product
- Product
- OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
- Manufacturer
- Exactech, Inc.
- Affected units
- 2,774
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Item Number (Device Identifier
- Serial number(s)): 252-12-01 (10885862065759
- 0757895
- 0757903
- 0757904
- 0757912
- 0779752
- 0779753
- 0779755
- 0779756
- 0779757
- 0779761
- 0779762
- 0779763
- 0779764
- 0779765
- 0779766
- 0779768
- 0779769
- 0779771
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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