Recall of Spohn Shoulder System Kits Due to Glove Splitting Risk
Resource Optimization & Innovation LLC is recalling 112 sterile Spohn Shoulder System kits 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 involves a risk-of-harm product (sterile field breach) where injury has not yet been reported, fitting the 'High' severity criteria for medical devices with potential for infection or procedural failure.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 112 sterile Spohn Shoulder System kits (Item Number: 800415001, OR0484A). The recall involves custom procedure trays that contain a light glove component.
The recall was initiated because the light glove can split during application to a light handle. This failure 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. The specific lot code is 026390A with an expiration date of July 13, 2017. Healthcare facilities and consumers should stop using these kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 112
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 (1)
- 026390A Exp Date 2017-07-13
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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