Z-1438-2023Class II

Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard...

Name: Z-1438-2023 Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard...
Creator: ROi CPS LLC
Published: 2023-03-22
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2023-03-22 / Open, Classified / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3... on 2023-03-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1438-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-22
Posted: 2023-04-25
Recalling firm: ROi CPS LLC
Product: 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.
Product code: OJH Orthopedic Tray
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued letters dated 3/22/2023 via email the same day. The letter explained the issue, identified the affected product, and listed the actions to be taken by the customer. The actions included checking their inventory for the affected product, segregate and quarantine all affected kits in their inventory, and use the attached label template to print warning labels to be affixed to all affected kits in their inventory. The label should be applied to each affected kit and outer product case in a prominent location to end users of the kits. The location chosen should not cover critical product information found on the existing label. The label instructs users to remove and discard the STERIS Light Handle Cover(s) when the kit is opened for use and to pull a sterile replacement from stock. A reply form is included with the letter for completion to indicate the consignee's actions in response to the notice. The response form is to be returned to the recalling firm via email. If the direct account consignee further distributed or forwarded the affected product, they are to immediately notify those customers. A copy of the ROi CPS recall letter, the letter from STERIS, and the attached label template may be included.
Quantity in commerce: 1,369 kits
Distribution: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1438-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1431-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-25
Z-1432-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-25
Z-1433-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-25
Z-1434-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-25
Z-1435-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-25
Z-1436-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-25
Z-1437-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-25
Z-1438-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-25

Product code OJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)