Recall of Regard Total Knee Procedure Trays Due to Glove Splitting
Resource Optimization & Innovation LLC is recalling 22 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.
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 is classified as FDA Class II. The hazard involves breaking the sterile field during a surgical procedure, which poses a risk of harm (infection) even though no specific injuries are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 22 kits of Regard sterile total knee procedure trays (Item Number: 880331001, OR0762A - Total Knee - OSU). The affected units were distributed to locations in Louisiana and Texas. The recall involves two specific lot codes: 031017A (expiration date 2017-11-30) and 032617A (expiration date 2018-03-30).
The recall was initiated because the trays contain a light glove component that can split during application to a light handle. This defect can break the sterile field, which is a critical safety requirement for surgical procedures. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
Healthcare facilities and consumers who have these specific procedure trays should stop using them immediately. Affected parties should contact the recalling firm, Resource Optimization & Innovation LLC, for instructions on how to return or dispose of the product.
The recalled product
- Product
- Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 22
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 (2)
- 031017A Exp Date 2017-11-30
- 032617A Exp Date 2018-03-30
Distribution
Part of a larger recall action
This product is one of 135 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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