Resource Optimization & Innovation Recalls Sterile Total Knee Surgical Kits
Resource Optimization & Innovation LLC is recalling 40 sterile total knee surgical kits because equipment glove components may contain splits or holes that compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility is compromised, posing a risk of infection (high-risk hazard), but the source text does not report any illnesses or injuries, placing it at the maximum score of 3 per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 40 sterile total knee surgical kits (Item Number 880331, OR0762). The kits are custom procedure trays containing surgical instruments and accessories intended for use during a surgical procedure. The recall is due to equipment glove components within the kits that may contain splits or holes, which could compromise the sterility of the product.
The affected lots are 20197, 22095, and 23379. Distribution was made to facilities in Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, located in St. Louis, Missouri.
Healthcare facilities should stop using the affected kits and contact the recalling firm for instructions on return or disposal. Patients who have already had surgery using these kits should consult their healthcare provider if they have concerns about potential sterility compromise.
The recalled product
- Product
- regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical p
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot numbers 20197
- 22095
- and 23379.
Distribution
Part of a larger recall action
This product is one of 77 recalled by Resource Optimization & Innovation 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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