Lower risk Medical device recall · FDA · Published January 13, 2022

Regard TOTAL HIP - SPRINGFIELD recalled due to mislabeled kit

ROi CPS recalls Regard TOTAL HIP - SPRINGFIELD kits with incorrect labeling on individual kits. This mislabeling may cause confusion in surgical use. Affected kits have specific item and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0693-2022Medical device ROi CPS ›

Lower-risk recall

Products are mislabeled with the incorrect product identification on individual kit labeling.

Take action

Contact the company

Recalling firmROi CPS LLC3000 E Sawyer Rd · Republic, MO 65738-2758

✎ GovInfoNow plain-language explainer

ROi CPS is recalling Regard TOTAL HIP - SPRINGFIELD surgical kits because they are mislabeled with the wrong product identification on individual kit labels. This could lead to confusion during surgical procedures if the wrong kit is used. Read more at govinfonow.com/recall/61268-regard-total-hip-springfield-recalled-due-to-mislabeled-kit.

Source Summary by GovInfoNow · govinfonow.com/recall/61268-regard-total-hip-springfield-recalled-due-to-mislabeled-kit · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0693-2022

Cite this page

“Regard TOTAL HIP - SPRINGFIELD recalled due to mislabeled kit.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/61268-regard-total-hip-springfield-recalled-due-to-mislabeled-kit. Based on FDA recall #Z-0693-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0693-2022%22&limit=1).

ROi CPS LLC voluntarily recalled Regard, TOTAL HIP - SPRINGFIELD medical kits due to mislabeled product identification on individual kit labeling, according to the FDA. The Food and Drug Administration announced the Class II recall on Jan. 13, 2022.

How to tell if you have it

Brand: ROi CPS
Product: Regard, TOTAL HIP - SPRINGFIELD
Item No.: 8800297010
Lot No.: 90328
UDI: 10194717113164
Distribution: Missouri

The hazard

The products are mislabeled with the incorrect product identification on individual kit labeling, according to the FDA.

Context

GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since Jan. 3, 2020. Other recent recalls of similar products include Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025) and Medline TRACH TUBE KIT Recall (July 10, 2026).

How to tell if you have this one

Check for item number 8800297010 and lot number 90328 on the kit packaging. The kits are sterile and sold in cases of two.

Brand
ROi CPS
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Labeling
Verify the item number and lot number on the kit packaging to confirm if it matches the recalled items.

Where it went and when

Where it was distributed

Distributed in Missouri.

FDA distribution: “Missouri” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Missouri.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

Jan 13, 2022Firm started the recall
Feb 28, 2022FDA classified it Class II
Mar 9, 2022Published in FDA’s Enforcement Report
Sep 28, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More ROi CPS recalls

Link to this recall

<a href="https://govinfonow.com/recall/61268-regard-total-hip-springfield-recalled-due-to-mislabeled-kit">Regard TOTAL HIP - SPRINGFIELD recalled due to mislabeled kit (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0693-2022 (January 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0693-2022 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.