Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants and instruments because directions for use and surgical techniques were not provided to every physician for every surgery.
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, and no injuries or illnesses are reported in the source text.
Plain-English summary
Orthopedic Alliance LLC has initiated a recall of 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 tibial baseplates, tibial inserts, and a variety of hip and knee implants and instruments. The source text identifies 459 units involved in the recall, which were distributed nationwide, including in California, Maryland, Texas, Nevada, and Wisconsin.
Consumers and healthcare providers should stop using the affected loaner bins and sterilization trays. Orthopedic Alliance LLC is the recalling firm responsible for this action.
The recalled product
- Product
- Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm…
- Manufacturer
- Orthopedic Alliance LLC
- Affected units
- 459
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
Same manufacturer · Orthopedic Alliance LLC
See all →- ModerateOrthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants
FDA (Devices) · 2013-06-05
- LowOrthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Documentation Issues
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