Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants
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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 failure (missing directions for use) rather than a direct physical defect or contamination, fitting the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays used for orthopedic 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 femoral components for hip and knee implants, specifically cemented and PS types in various sizes for left and right sides. The recall covers 136 units that were distributed nationwide, including in California, Maryland, Texas, Nevada, and Wisconsin.
Physicians and healthcare facilities should stop using the affected loaner bins and sterilization trays and contact Orthopedic Alliance for further instructions regarding the missing documentation.
The recalled product
- Product
- Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral…
- Manufacturer
- Orthopedic Alliance LLC
- Hazard
- Affected units
- 136
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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