Resource Optimization Recalls Sterile Total Knee Procedure Trays Due to Glove Defect
Resource Optimization & Innovation LLC is recalling eight sterile total knee procedure trays because a light glove component can split during use, potentially 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 involves a risk-of-harm product (sterile surgical tray) where a defect can break the sterile field, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation LLC is recalling eight kits of Regard sterile total knee procedure trays (Item Number: 880331002, OR0762B - Total Knee - OSU). The recall involves specific lots with expiration dates of June 30, 2018, and October 31, 2018.
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 affected products were distributed in the United States to locations in Louisiana and Texas. No specific injuries or illnesses have been reported in the source text. Healthcare facilities should stop using these specific trays and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 8
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)
- 038832B Exp Date 2018-06-30
- 040636B Exp Date 2018-10-31
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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