Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants because directions for use and surgical techniques 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 source text indicates the issue is a documentation failure (missing instructions) rather than a physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Orthopedic Alliance LLC has initiated a recall of Loaner Bin 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 Co-Cr cancellous bone screws in various lengths (15mm, 20mm, 25mm, 30mm, 35mm, and 40mm) as well as a variety of hip and knee implants and instruments. The recall covers 5 units of these items, identified by item numbers 5201-6715, 5201-6720, 5201-6725, 5201-6730, 5201-6735, and 5201-6740.
The products were distributed nationwide, including in the states of California, Maryland, Texas, Nevada, and Wisconsin. Physicians and healthcare facilities should verify if they have received these specific items and ensure that all necessary directions for use and surgical techniques are available for any future procedures involving these devices.
The recalled product
- Product
- Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
- Manufacturer
- Orthopedic Alliance LLC
- Affected units
- 5
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 (1)
- Item No. 5201-6715 5201-6720 5201-6725 5201-6730 5201-6735 5201-6740
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.
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