Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Documentation Issues
Orthopedic Alliance LLC is recalling 30 units of 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for documentation issues (missing directions for use) without reported injuries or illnesses, fitting the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Orthopedic Alliance LLC is recalling 30 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 U2 Acetabular cups (Ti beads porous coated) in various sizes (44mm to 62mm) and U2 Acetabular cup liner assemblies (10° hooded, 44mm to 62mm). The recall covers a variety of hip and knee implants and instruments. The products 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 LLC for further instructions regarding the missing documentation.
The recalled product
- Product
- U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads…
- Manufacturer
- Orthopedic Alliance LLC
- Hazard
- Affected units
- 30
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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