ROi CPS LLC: 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: 88042700

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. Quantity: 1,369 kits Lot/code info: 1. Lot #95080, exp. 9/7/2024, UDI (01)10194717114161(17)240907(10)95080; 2. Lot #95381, exp. 5/30/2024, UDI (01)10194717112341(17)240530(10)95381; 3. Lot #95516, exp. 9/30/2024, UDI (01)10194717112365(17)240930(10)95516; 4. Lot #95388, exp. 10/29/2024, UDI (01)10194717114192(17)241029(10)95388; 5. Lot #95310, exp. 10/27/2024, UDI (01)10194717112778(17)241027(10)95310; 6. Lot #95503, exp. 12/31/2023, UDI (01)10194717112150(17)231231(10)95503; 7. Lot #95667, exp. 10/29/2024, UDI (01)10194717113904(17)241029(10)95667; 8. Lot #95634, exp. 11/30/2024, UDI (01)10194717114154(17)241130(10)95634; 9. Lot #95555, exp. 11/29/2024, UDI (01)10194717111016(17)241129(10)95555; 10. Lot #95769, exp. 10/29/2024, UDI (01)10194717114185(17)241029(10)95769; 11. Lot #95422, exp. 11/30/2024, UDI (01)10194717114178(17)241130(10)95422; and 12. Lot #95633, exp. 10/17/2024, UDI (01)10194717113713(17)241017(10)95633.

UPC codes

10194717114161, 10194717112341, 10194717112365, 10194717114192, 10194717112778, 10194717112150, 10194717113904, 10194717114154, 10194717111016, 10194717114185, 10194717114178, 10194717113713

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.