Orthopedic Alliance Recalls Bipolar Caps Due to Missing Surgical Instructions
Orthopedic Alliance LLC is recalling 37 Bipolar Caps 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 does not report any illnesses, injuries, or hospitalizations. 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 37 units of Bipolar Caps in various sizes (ID26mm-OD42mm through ID28mm-OD56mm). The affected items include Item Nos. 1503-3042, 1503-3144, 1503-3146, 1503-3148, 1503-3150, 1503-3152, 1503-3154, and 1503-3156.
The recall was initiated because the directions for use and surgical techniques were not being provided to every physician and for every surgery. The products were distributed nationwide, including in California, Maryland, Texas, Nevada, and Wisconsin.
Physicians and healthcare facilities should stop using the affected Bipolar Caps and contact Orthopedic Alliance LLC for instructions on how to return the devices.
The recalled product
- Product
- Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm
- Manufacturer
- Orthopedic Alliance LLC
- Hazard
- Affected units
- 37
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.
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