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.
What this means for you
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 compone
- 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
Same manufacturer · Orthopedic Alliance LLC
See all →- ModerateOrthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
FDA (Devices) · 2013-06-05
- LowOrthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Documentation Issues
FDA (Devices) · 2013-06-05
- ModerateOrthopedic Alliance Recalls Loaner Bin and Sterilization Trays
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
Same hazard · documentation error
See all →- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModeratePower Over Fiber Base Modules Recalled Due to Incorrect Laser Classification and Labeling
FDA (Devices) · 2026-08-05
- ModerateEmbrace standard drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01