Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays
Orthopedic Alliance LLC is recalling 57 units of loaner bins and sterilization trays because surgical instructions 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 'Moderate' criteria for minor labeling/documentation errors.
Plain-English summary
Orthopedic Alliance LLC is recalling 57 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 various UKNEE Patella and UKNEE Onset Patella components, as well as a variety of hip and knee implants and instruments. The distribution was nationwide, including the states of California, Maryland, Texas, Nevada, and Wisconsin.
Consumers and healthcare providers should stop using these products and contact Orthopedic Alliance LLC for further instructions.
The recalled product
- Product
- UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE…
- Manufacturer
- Orthopedic Alliance LLC
- Hazard
- Affected units
- 57
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
FDA (Devices) · 2013-06-05
- ModerateOrthopedic Alliance Recalls Bipolar Caps Due to Missing Surgical Instructions
FDA (Devices) · 2013-06-05
- ModerateOrthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants
FDA (Devices) · 2013-06-05
- ModerateOrthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
FDA (Devices) · 2013-06-05
Same hazard · documentation error
See all →- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateSpinal Solutions Recalls Loaner Bins and Sterilization Trays for Missing Instructions
FDA (Devices) · 2013-06-05
- SevereBiomet Recalls Oxford Partial Knee Trial Trays Due to Material Inclusions
FDA (Devices) · 2017-03-01
- SevereBiomet Recalls Oxford Knee Instruments Due to Material Inclusions
FDA (Devices) · 2017-03-01
- HighBiomet Oxford Knee Instruments Recalled for Potential Material Inclusions
FDA (Devices) · 2017-03-01
- ModerateSpinal Solutions Recalls Loaner Bins Due to Missing Surgical Instructions
FDA (Devices) · 2013-06-05
- HighBiomet Oxford Knee Instruments Recalled for Material Inclusions
FDA (Devices) · 2017-03-01