Reported May 3, 2023 · Ongoing
Sterile surgical convenience kits
ROi CPS LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ROi CPS LLC · 3000 E Sawyer Rd · Republic, MO · 65738-2758
Is this the product you have?
Sterile surgical convenience kits
12 of 12 products
| Model / number | Product as published |
|---|---|
880473001 | regard , OR01105A - Total Shoulder/Hip |
880426004 | regard , OR01033D - Total Hip |
880427003 | regard , OR01034C - Total Knee |
880474001 | regard , OR01106A - Knee Arthroscopy |
800772006 | regard , OR00977F - OH Total Knee Pack |
880403004 | regard , OR01009D - Extremity Pack |
880472001 | regard , OR01104A - Basic Pack |
880470001 | regard , OR01102A - Total Knee |
800755006 | regard , OR00960F - OH Hip Pack |
880471001 | regard , OR01103A - Shoulder Arthroscopy |
880480001 | regard , OR01112A - Hand and Foot ; and |
880468001 | regard , OR01100A - Spine. |
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 10194717114161Lot #95080, exp. 9/7/2024, UDI (01)10194717114161(17)240907(10)95080 2 10194717112341Lot #95381, exp. 5/30/2024, UDI (01)10194717112341(17)240530(10)95381 3 10194717112365Lot #95516, exp. 9/30/2024, UDI (01)10194717112365(17)240930(10)95516 4 10194717114192Lot #95388, exp. 10/29/2024, UDI (01)10194717114192(17)241029(10)95388 5 10194717112778Lot #95310, exp. 10/27/2024, UDI (01)10194717112778(17)241027(10)95310 6 10194717112150Lot #95503, exp. 12/31/2023, UDI (01)10194717112150(17)231231(10)95503 7 10194717113904Lot #95667, exp. 10/29/2024, UDI (01)10194717113904(17)241029(10)95667 8 10194717114154Lot #95634, exp. 11/30/2024, UDI (01)10194717114154(17)241130(10)95634 9 10194717111016Lot #95555, exp. 11/29/2024, UDI (01)10194717111016(17)241129(10)95555 10 10194717114185Lot #95769, exp. 10/29/2024, UDI (01)10194717114185(17)241029(10)95769 11 10194717114178Lot #95422, exp. 11/30/2024, UDI (01)10194717114178(17)241130(10)95422; and 12 10194717113713Lot #95633, exp. 10/17/2024, UDI (01)10194717113713(17)241017(10)95633. - Amount recalled
- 1,369 kits
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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