Device product
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.
Z-1437-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91984
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 456 kits
- Official record key
device-enforcement:Z-1437-2023
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
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.