CLASS II ONGOING Device recall · Reported 3 May 2023 · FDA Enforcement Report
Sterile surgical convenience kits: regard recalled by ROi CPS
ROi CPS is recalling Sterile surgical convenience kits: regard, distributed nationwide in the US. The recall was initiated on 22 Mar 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1438-2023
- FDA event ID
- 91984
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Mar 2023
- FDA classified
- 25 Apr 2023
- Reported
- 3 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 22 Mar 2023 | Recall initiated by company | |
| 25 Apr 2023 | Classified by FDA | +34 days |
| 3 May 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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 Arthroscopy; 5. regard Item Number: 800772006, OR00977F - OH Total Knee Pack ; 6. regard Item Number: 880403004, OR01009D - Extremity Pack; 7. regard Item Number: 880472001, OR01104A - Basic Pack ; 8. regard Item Number: 880470001, OR01102A - Total Knee ; 9. regard Item Number: 800755006, OR00960F - OH Hip Pack ; 10. regard Item Number: 880471001, OR01103A - Shoulder Arthroscopy ; 11. regard Item Number: 880480001, OR01112A - Hand and Foot ; and 12. regard Item Number: 880468001, OR01100A - Spine.
Where it was distributed
US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 91984This product is part of a recall event; the main page for the event is Sterile surgical convenience kit: regard recalled by ROi CPS.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sterile surgical convenience kit: regard recalled by ROi CPS | ROi CPS | Other | Nationwide | |
| CLASS II | Sterile surgical convenience kit: regard recalled by ROi CPS | ROi CPS | Other | Nationwide | |
| CLASS II | Sterile surgical convenience kit: regard recalled by ROi CPS | ROi CPS | Other | Nationwide | |
| CLASS II | Sterile surgical convenience kits: regard recalled by ROi CPS | ROi CPS | Other | Nationwide | |
| CLASS II | Sterile surgical convenience kits: regard recalled by ROi CPS | ROi CPS | Other | Nationwide | |
| CLASS II | Sterile surgical convenience kits: regard recalled by ROi CPS | ROi CPS | Other | Nationwide | |
| CLASS II | Sterile surgical convenience kit: regard recalled by ROi CPS | ROi CPS | Other | Nationwide |
More recalls from ROi CPS
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | regard Item Number: 830106006, LD01114F - Newborn Kit containing recalled | ROi CPS | Potency & Assay | MO |
| Device | CLASS II | regard Clinical Packaging Solutions, HT00376I - Special Procedure recalled | ROi CPS | Packaging Defects | Nationwide |
| Device | CLASS II | Regard Kit containing the Microtek decanter recalled by ROi CPS | ROi CPS | Sterility | Nationwide |
| Device | CLASS I | regard Operative LAP recalled by ROi CPS | ROi CPS | Other | LA |
| Device | CLASS I | Regard Dressing change kit recalled by ROi CPS | ROi CPS | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,110| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |