Resource Optimization Recalls 18 Sterile Total Hip Procedure Trays
Resource Optimization & Innovation LLC is recalling 18 sterile total hip procedure trays because a light glove component can split and break the sterile field.
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 risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 18 kits of Regard sterile total hip procedure trays (Item Number: 880330003, OR0761C - Total Hip - OSU). The recall involves specific lots with expiration dates of October 30, 2017, and November 30, 2017. The affected products were distributed in the United States to locations in Louisiana and Texas.
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.
Healthcare facilities that received these specific trays should stop using them and contact the recalling firm for instructions on return or disposal. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Trays
- Affected units
- 18
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)
- 030590C Exp Date 2017-10-30
- 031852C Exp Date 2017-11-30
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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