Surgical Kit Light Handle Covers May Separate During Use

Plain-English summary

ROi CPS LLC is recalling 1,369 sterile surgical convenience kits due to a potential defect affecting light handle covers. The kits include 12 different product types used in various surgical procedures, including total shoulder/hip, total hip, total knee, knee arthroscopy, extremity, basic, hand/foot, and spine surgical packs. The light handle covers are components included in these convenience kits.

The manufacturer was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The affected kits span 12 lot numbers with expiration dates ranging from May 2024 through December 2024. Documented distribution includes facilities in Florida and Missouri, with nationwide U.S. distribution noted.

Healthcare facilities that have received affected kits should immediately discontinue use and contact ROi CPS LLC for replacement or further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product

Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthro

Manufacturer

ROi CPS LLC

Category

Medical Device — Surgical Convenience Kits

Hazard

• component-separation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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