Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling 21 loaner bins and sterilization trays 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 issue (missing instructions) rather than a direct physical defect or contamination, fitting the 'Minor labeling errors' or 'documentation issues' criteria for a Moderate score.
Plain-English summary
Orthopedic Alliance LLC is recalling 21 units of loaner bins and sterilization trays used for hip and knee 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 are distributed nationwide, including in California, Maryland, Texas, Nevada, and Wisconsin. The recall covers various femoral head sizes and offsets, as well as other hip and knee implants and instruments.
Physicians and healthcare facilities should stop using the affected loaner bins and sterilization trays and contact Orthopedic Alliance LLC for further instructions.
The recalled product
- Product
- Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm…
- Manufacturer
- Orthopedic Alliance LLC
- Hazard
- Affected units
- 21
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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