Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.
Enforcement
- Recall Number
- Z-1437-2023
- Event ID
- 91984
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ROi CPS LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 3, 2023
- Initiation Date
- March 22, 2023
- Classification Date
- April 25, 2023
- Address
- 3000 E Sawyer Rd, N/A, Republic, MO, 65738-2758, United States
Description
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
1. Lot #95370, exp. 10/29/2024, UDI (01)10194717111023(17)241029(10)95370; 2. Lot #95477, exp. 6/30/2024, UDI (01)10194717112242(17)240630(10)95477; 3. Lot #95506, exp. 5/31/2024, UDI (01)10194717114130(17)240531(10)95506; 4. Lot #95632, exp. 5/30/2024, UDI (01)10194717112709(17)240530(10)95632; and 5. Lot #95646, exp. 11/15/2024, UDI (01)10194717110880(17)241115(10)95646, and Lot #95309, exp. 10/29/2024, UDI (01)10194717110880(17)241029(10)95309.
US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
456 kits