Resource Optimization & Innovation Recalls Sterile Total Knee Surgical Kits
Resource Optimization & Innovation LLC is recalling 200 sterile total knee surgical kits because the equipment glove component may have splits or holes that compromise sterility.
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 3/5 (High).
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 sterile medical device where sterility may be compromised, posing a risk of infection. No illnesses or injuries are reported in the source text, and the agency classification is Class II, which aligns with a High severity score for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 200 sterile total knee surgical kits (Item Number 800553, OR0642). The kits contain surgical instruments and accessories intended for use during a surgical procedure. The recall is due to the equipment glove component potentially containing splits or holes that may compromise the sterility of the kit.
The affected lots are 17133, 18156, 19422, 19971, 20643, and 21129. Distribution was made to Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, located in St. Louis, MO.
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: 800553, Sterile, OR0642 - 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…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 200
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 (6)
- Lot numbers 17133
- 18156
- 19422
- 19971
- 20643
- and 21129.
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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