Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling 50 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician for every surgery.
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 issue (missing directions for use) rather than a direct physical defect or contamination, fitting the criteria for moderate severity involving procedural or labeling errors without reported injuries.
Plain-English summary
Orthopedic Alliance LLC is recalling 50 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 Zweimueller Type Stems in various sizes and types (SCS-Standard, SCL-Lateralized, and SCR-Revision), as well as a variety of hip and knee implants and instruments. The recall covers nationwide distribution, including the states of 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
- Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type Stem SCS-Standard Sz 2 Zweimueller Type Stem SCS-Standard Sz 3 Zweimueller Type Stem SCS-Standard Sz 4 Zweimueller Type Stem SCS-Standa
- Manufacturer
- Orthopedic Alliance LLC
- Affected units
- 50
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
- 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
- ModerateOrthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
FDA (Devices) · 2013-06-05
Same hazard · missing instructions
See all →- ModerateDrug transfer devices recalled for shipping without US instructions for use
FDA (Devices) · 2025-09-03
- ModerateIntravenous Sodium Chloride Injection Recalled for Incomplete Labeling and Warnings
FDA (Drugs) · 2023-08-16
- HighCarefusion Bipolar Forceps Recalled Due to Incomplete Instructions
FDA (Devices) · 2022-12-14
- HighBipolar Forceps Recalled for Missing Power Supply and Cleaning Instructions
FDA (Devices) · 2022-12-14
- HighEKOS Control Unit 4.0 Recalled for Missing or Incorrect Instructions
FDA (Devices) · 2022-11-09