[Recalled] Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn — Custom procedure trays contain a component, a light glove, that has been recall… | FDA 2017-01-09

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Resource Optimization & Innovation Llc

• Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills — Class II
• Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa — Class II
• Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn — Class II
• Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo — Class II
• Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU — Class II
• Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.