Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays
Orthopedic Alliance LLC is recalling 57 units of loaner bins and sterilization trays because surgical instructions were not provided to every physician.
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: The recall is classified as FDA Class II, but the hazard is a documentation issue (missing instructions) rather than a direct physical defect or contamination, fitting the 'Moderate' criteria for minor labeling/documentation errors.
Plain-English summary
Orthopedic Alliance LLC is recalling 57 units of Loaner Bins and Sterilization Trays used for implants and instruments. The recall was initiated because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
The affected products include various UKNEE Patella and UKNEE Onset Patella components, as well as a variety of hip and knee implants and instruments. The distribution was nationwide, including the states of California, Maryland, Texas, Nevada, and Wisconsin.
Consumers and healthcare providers should stop using these products and contact Orthopedic Alliance LLC for further instructions.
The recalled product
- Product
- UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE
- Manufacturer
- Orthopedic Alliance LLC
- Hazard
- Affected units
- 57
Distribution
Part of a larger recall action
This product is one of 9 recalled by Orthopedic Alliance LLC 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.
See all 9 products in this recall →Related recalls
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