Recall of Spohn Shoulder System Kits Due to Light Glove Splitting
Resource Optimization & Innovation LLC is recalling 208 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 (medical device) where the defect (breaking the sterile field) poses a significant risk of infection, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 208 kits of the Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn. The recall involves specific lots with expiration dates of August 23, 2018, September 28, 2018, and December 9, 2018.
The recall was initiated because the custom procedure 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 illnesses or injuries have been reported in the source text. Healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 208
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 (3)
- 037610C Exp Date 2018-08-23
- 038494C Exp Date 2018-09-28
- 040237C Exp Date 2018-12-09
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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