Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions
Orthopedic Alliance LLC is recalling 26 loaner bins and sterilization trays 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 source text explicitly states no illnesses or injuries were reported and the hazard is procedural (missing instructions) rather than a direct physical defect causing harm, fitting the criteria for a moderate severity score.
Plain-English summary
Orthopedic Alliance LLC is recalling 26 units of Loaner Bin 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 were distributed nationwide, including in California, Maryland, Texas, Nevada, and Wisconsin. The recall covers specific part numbers associated with ceramic and CoCr ball heads, including 194.01.28, 194.02.28, 194.03.28, 195.01.32, 195.02.32, 195.03.32, 188.01.28, 188.02.28, 188.03.28, 188.04.28, 188.05.28, 189.01.32, 189.02.32, and 189.03.32.
Physicians and healthcare facilities should stop using the affected loaner bins and sterilization trays and contact Orthopedic Alliance LLC for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMIC Ball Head, 32 Long CERAMIC Ball Head, 28 Short CoCr Ball Head, 28 Medium CoCr Ball Head, 28 Long CoCr Ball Head, 28 X-Long CoCr…
- Manufacturer
- Orthopedic Alliance LLC
- Affected units
- 26
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 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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSpinal Solutions Recalls Loaner Bins and Sterilization Trays for Missing Instructions
FDA (Devices) · 2013-06-05
- ModerateSpinal Solutions Recalls Loaner Bins Due to Missing Surgical Instructions
FDA (Devices) · 2013-06-05
- SevereCustomed Orthopedic Trays Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- ModerateSpinal Solutions Recalls Copperhead IBFD Loaner Bins Due to Missing Instructions
FDA (Devices) · 2013-06-05
- SevereOrthopedic Alliance Recalls Blue & Gold Spine System Implants
FDA (Devices) · 2013-05-01
- HighResource Optimization Recalls 18 Sterile Total Hip Procedure Trays
FDA (Devices) · 2017-04-05